- Email: [email protected]
Quality improvement in tracheostomy care: A multidisciplinary approach to standardizing tracheostomy care to reduce complications
Journal Pre-proof Quality improvement in tracheostomy care: A multidisciplinary approach to standardizing tracheostomy care to reduce complications
Samuel J. Rubin, Stefanie S. Saunders, Jacob Kuperstock, Dominick Gadaleta, Peter A. Burke, Gregory Grillone, James M. Moses, Jaime P. Murphy, Gerardo Rodriguez, Andrew Salama, Michael P. Platt PII:
S0196-0709(19)31047-6
DOI:
https://doi.org/10.1016/j.amjoto.2019.102376
Reference:
YAJOT 102376
To appear in:
American Journal of Otolaryngology--Head and Neck Medicine and Surgery
Received date:
8 December 2019
Please cite this article as: S.J. Rubin, S.S. Saunders, J. Kuperstock, et al., Quality improvement in tracheostomy care: A multidisciplinary approach to standardizing tracheostomy care to reduce complications, American Journal of Otolaryngology--Head and Neck Medicine and Surgery(2019), https://doi.org/10.1016/j.amjoto.2019.102376
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© 2019 Published by Elsevier.
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Quality Improvement in Tracheostomy Care: A Multidisciplinary Approach to Standardizing Tracheostomy Care to Reduce Complications Samuel J. Rubin, MD, MPHa, [email protected] Stefanie S. Saunders, MD, MSca, [email protected] Jacob Kuperstock, MDa, [email protected]
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Dominick Gadaleta, MDa
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[email protected]
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Peter A. Burke, MDb [email protected]
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Gregory Grillone, MDa [email protected]
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Gerardo Rodriguez, MDe [email protected]
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Jaime P Murphy, MDd [email protected]
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James M. Moses, MD, MPHc [email protected]
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Andrew Salama, MD, DDSf [email protected] Michael P. Platt, MD, MSca [email protected] a
Department of Otolaryngology – Head and Neck Surgery, Boston University School of Medicine, Boston, Massachusetts, USA b
Department of General Surgery, Section of Trauma and Acute Care Surgery, Boston University School of Medicine, Boston, Massachusetts, USA c
Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts, USA
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d
Department of Pulmonary Medicine, Critical Care and Allergy, Boston University School of Medicine, Boston, Massachusetts, USA e
Department of Anesthesiology, Boston University School of Medicine, Boston, Massachusetts, USA f
Department of Oral & Maxillofacial Surgery, Henry M. Goldman School of Dental Medicine, Boston, Massachusetts, USA
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Corresponding Author: Michael P. Platt, MD, MSc, Department of Otolaryngology – Head and Neck Surgery, 800 Harrison Ave., BCD 5th floor, Boston, MA 20118, USA. Phone: 617-638-7669. Fax. 617-6387965 Email: [email protected]
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Presented at: Triological Society, Combined Otolaryngology Section Annual Meeting, Chicago, IL, May, 2016
Sources of Funding: None
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Conflicts of Interest: None
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Abstract Purpose: Develop a model for quality improvement in tracheostomy care and decrease tracheostomy-related complications. Methods: This study was a prospective quality improvement project at an academic tertiary care hospital. A multidisciplinary team was assembled to create institutional guidelines for clinical care during the pre-operative, intra-operative, and post-operative periods. Baseline data was
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compiled by retrospective chart review of 160 patients, and prospective tracking of select points
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over 8 months in 73 patients allowed for analysis of complications and clinical parameters.
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Results: Implementation of a quality improvement team was successful in creating guidelines,
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setting baseline parameters, and tracking data with run charts. Comparison of pre- and postguideline data showed a trend toward decreased rate of major complications from 4.38% to
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2.74% (p=0.096). Variables including time to tracheotomy for prolonged intubation, surgical
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technique, day of first tracheostomy tube change, and specialty performing surgery did not show
cold months (p=0.04).
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increased risk of complications. There were increased tracheostomy-related complications in
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Conclusions: An interdisciplinary quality improvement team can improve tracheostomy care by identifying system factors, standardizing care among specialties, and providing continuous monitoring of select data points.
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Introduction Tracheostomy is one of the most common surgical procedures performed in the United States annually with an average of approximately 100,000 cases performed per year or 34.3 cases per 100,000 US adults with an increase of 106% in the number of cases between 1993-2012 [1]. Tracheotomy is performed for multiple indications including: airway obstruction, prolonged intubation, airway malignancy, and copious secretions [2]. Those patients that require
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tracheostomy for prolonged intubation and mechanical ventilation have a significant economic
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effect on US healthcare spending with an estimated mean value of $306,135±$285467 per year
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per patient [3]. There are multiple surgical options and post-operative care decisions that impact
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both safety and cost-effectiveness of care for patients with tracheostomies with reported complication rates of 1.4%, 5.6%, and 7.1% for intraoperative, early, and late complications,
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respectively [4,5]. The appropriate care and maintenance of tube patency is crucial to avoiding
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serious complications, including infection, bleeding, accidental decannulation, and obstruction from granulation tissue formation or secretions [4]. The most serious tracheostomy-related
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complications can result in anoxic brain injury or death [6-8].
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Multiple teams and clinical factors contribute to tracheostomy placement decisions and care. With multiple specialties and surgeons performing and caring for tracheostomies, there is wide variation in clinical practice. There have been a limited number clinical guidelines published which describe the standard of care for management of patients with tracheostomy tubes [9,10]. Additionally, it is difficult to manage these complex tracheostomy patients without a multidisciplinary team including providers involved in all aspects of the patient’s care. These multidisciplinary teams have demonstrated decreased time to decannulation, decrease rate of adverse events, shorter lengths of stay in the ICU and reduced hospital length of stay [11-14].
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With a lack of consistency in tracheostomy care and metrics, limited publications on clinical guidelines, the high rate of morbidity and mortality, and the high cost to the healthcare system, standardizing care is of priority. The aim of this project was to standardize best practices at all stages of tracheostomy care: before, during, and after surgery, to decrease overall complications at a single institution. This was accomplished by development of comprehensive multidisciplinary clinical guidelines for tracheostomy care, implementation of tracheostomy
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education in all training programs who participate in care of patients with tracheostomy tubes,
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and development of instruments that can be used in clinical care to decrease complication rates.
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Methods Overview
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This study was designed as a quality improvement initiative at a single academic tertiary
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care hospital, and therefore was exempt from the Boston University School of Medicine Institutional Review Board approval. The plan-do-study-act (PDSA) cycle was employed, which
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is a methodology in Quality Improvement (QI) projects in health care to identify baseline data,
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plan change, and measure the change [15]. A retrospective chart review was performed to obtain baseline data. From that data guidelines were developed to implement change. Finally, multiple variables that were determined to be clinically important by the multi disciplinary team based on expert opinion and literature were then tracked to determine if implemented changes resulted in a decrease in complication rates. Secondary medically related factors were also identified and measured that were thought to contribute to complication rates.
Baseline Data Collection
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A retrospective chart review was performed that included all patients (n=160) who underwent tracheotomy at Boston Medical Center (BMC) over a 15 month period (June 1, 2012September 1, 2013). Patients were identified by searching inpatient ICD-9 procedure codes for the following: temporary tracheostomy (31.1), and other permanent tracheostomy (31.29). Baseline data was collected and recorded including patient age, sex, height, weight, body mass index (BMI), medical comorbidities, length of stay, indication for tracheostomy, days intubated
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prior to tracheostomy, technique used, first tracheostomy tube change post-operative day,
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tracheostomy related complications, and number of days in intensive care.
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Data was collected and maintained on an Excel (Microsoft Corp., Redmond, WA, USA)
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spreadsheet and saved on secure institutional networks. Indications for tracheostomy included prolonged intubation, acute respiratory failure, neoplasm, and trauma. Technique for
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tracheotomy included the use of secondary airway stabilization techniques such as a Bjork flap
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or stay sutures. Tracheostomy related complications were classified as either major or minor based on the expert opinion of the multidisciplinary team. All complications were identified
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during the initial hospital stay. Major complications included a loss of airway stability: false
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passage, desaturation requiring emergent resuscitation (code called), loss of airway, and hemorrhage requiring emergent intervention. Minor complications included tracheitis, pneumonia (developed after tracheostomy placement), mucus plugging, self-decannulation (without “code”), luminal occlusion (granulation), and minor bleeding without operative intervention. Intervention: Multidisciplinary Team and Guideline Development A multidisciplinary team was assembled to identify causes and contributing factors for tracheostomy-related complications, as well as develop an institutional consensus regarding the
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appropriate management of patients with tracheostomy tubes. All disciplines and specialties who are involved in tracheostomy tube care were included: Anesthesiology, General Surgery, Nursing, Nursing Education, Oral and Maxillofacial Surgery, Otolaryngology, Pulmonology, Quality Improvement / Safety, Respiratory Therapy, and Speech Pathology. Hospital-wide guidelines for tracheostomy care were then developed using baseline data, published reports, and expert opinion, for the preoperative, intraoperative, and postoperative
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periods. Guidelines were distributed to all departments and teams involved in all stages of
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tracheostomy care. Briefly, the guidelines recommend: 1. Performing tracheostomy within 14
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days for prolonged intubation (begin the process after 7 days of intubation); 2. The decision for
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tracheotomy technique (percutaneous, open, use of secondary means of stabilization) should consider patient factors (anatomy) and the risk of future airway loss (Figure 1); 3. The first
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tracheostomy tube change should be performed between day 5 and day 10 post-operatively by
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the team who performed the procedure. A checklist was created to assist in preparedness for the change (Table 1); 4. A multidisciplinary team should be involved in tracheostomy tube
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management including decisions for downsizing, use of speaking valve, capping trials, and
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decannulation.
A gap analysis was performed to identify causative factors in the care of patients with tracheostomy tubes that contribute to clinical variability and complications. Factors included were those associated with patient comorbidities, indications for tracheostomy, preoperative care, tracheostomy technique, postoperative care, and complications (Figure 2). These factors were selected based on published literature and the consensus and expert opinion of the multidisciplinary team.
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Plan-Do-Study-Act (PDSA) The selected clinical data points were tracked on a monthly basis over an 8-month period following guideline distribution and education (July 1, 2014- March 1, 2015). This was done for all new tracheostomy patients to determine if implemented changes resulted in decreased complication rates. All PDSA changes were implemented at once after the multidisciplinary meeting. The 14 clinical data points included: age, length of stay, length of intubation, BMI, sex,
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indication, technique, prior intubation, diabetes, cardiovascular disease, neurological disease,
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weather months included October to March.
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prior tobacco use, and weather. Hot weather months included April to September whereas cold
Data Analysis
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The primary clinical outcome for this project was tracheostomy complication rates before
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and after the implementation of a standardized tracheostomy management protocol. Additional data on comorbidities were also recorded. Statistical software SAS Version 9.3 (SAS Institute
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Inc., Cary, NC) was used for all statistical analysis. Mean and Standard deviation were recorded
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for all continuous variables, and frequencies and proportions were recorded for all categorical variables. Data was not assumed to be parametric. A test of variance was performed for all continuous data and a Kruskal-Wallis test was used to measure the difference between continuous variables. A chi-square test was used to compare the frequencies of all categorical variables. Multiple logistic regression analysis was performed to examine the association between tracheostomy complications, including both major and minor complications, and the predictor variables including obesity, hot (April-September) or cold (October- March) weather, the use of secondary stabilization methods when performing the tracheotomy procedure, and the
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first tracheostomy tube change at or before day 5 after initial procedure. All data with an alpha level < 0.05 was determined to be significant.
Results Baseline (pre-intervention) data was collected for 160 tracheostomy patients over 1 year. Of the included patients, 105 were males (65.6%) and 55 were females (34.4%) with a mean age
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of 54.8 years. Tracheostomies were performed for prolonged intubation (49.4%), neoplasm
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(39.4%), trauma (6.2%), and acute respiratory failure (5%). Secondary stabilization techniques
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with Bjork flap or stay sutures were performed in 87.5% of cases based on surgeon preference.
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There were no complications in the majority of patients (86.88%). Major complications were recorded in 4.38%, and minor complications were recorded in 8.75% of patients (Tables 2,3).
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Tracheostomies were prospectively tracked monthly over an 8-month period following
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guideline development, distribution, and education (n=73). Similar demographics were again recorded as in the pre-intervention group. Of these patients, 39 were male (53.4%), 34 were
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female (46.6%) with a mean age of 58.4 years. Tracheostomies were performed for prolonged
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intubation (32.9%), neoplasm (54.8%), trauma (5.5%), and acute respiratory failure (6.8%). The overall complication rate was 16.4%, with major complications seen in 2.7% of patients, and minor complications in 13.7% of patients. (Tables 1, 2)(Figure 3). Additionally, the major complication rate pre-intervention was 4.38% and the major complication rate post-intervention was 2.74%. This was an overall reduction by 71.4% (p=0.096). Factors contributing to complications before and after intervention were reported. There was no significant difference in 13 of the 14 variables (Table 4). The only factor associated with complications in tracheostomy management was the time of year and associated climate in
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Boston, Massachusetts (p=0.034). In the logistic regression analysis, there was a significant association between tracheostomy complications and weather at time of complication after controlling for obesity, the use of secondary stabilization methods, and first tracheostomy tube change before at or before day 5. Patients that underwent tracheotomy in the cold months of the year (October-March) have 2.49 times the odds of having a complications compared to patients
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that underwent tracheotomy in the hot months of the year (95%CI (1.111, 5.584); p=0.027).
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Discussion
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This study describes the process of developing a multidisciplinary tracheostomy
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management protocol and implementing this protocol in a single institution with its associated outcomes. A variety of factors were investigated in an attempt to standardize tracheostomy care
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across specialties and caregivers by obtaining baseline metrics that could be tracked overtime to
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assess change. In determining the baseline data, areas of potential improvement were identified via multidisciplinary team discussion, and guidelines were developed to standardize care. Using
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change.
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the PDSA cycle model, clinical points were identified and successfully tracked to measure
Major and minor complications of tracheostomy are well documented and various studies have reported an incidence of 3.8% to 97% in open tracheotomies [16]. Shah et al reported an overall complication rate of 3.2%, and a mortality rate of 19.2% in 113,653 tracheostomies that were performed nationally in 2012 [17]. Das et al estimate 1000 catastrophic events annually, 500 of which lead to death or permanent disability [18]. There is no doubt that the frequency of tracheostomy complications and potential for catastrophic complications necessitate quality improvement methods for improving care in patients with tracheostomy tubes.
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In this quality improvement project, the major complication rate was 4.38% in the preintervention group and 2.74% in the post-intervention group. These rates are similar to those reported in the literature. Since major complications are a less common occurrence at a single institution, a larger sample size, possibly via a multicenter study, are needed to obtain higher power. The finding that patients who underwent tracheotomy in the cold months of the year
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(October-March) have 2.49 times the odds of having a complications compared to patients that
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underwent tracheotomy in the hot months of the year (95%CI (1.111, 5.584); p=0.0267) has not
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been previously reported. This may be a seasonal component due to dry indoor heat in the cold
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months leading to tracheitis, bleeding, and mucous plugging. Mucus plugging leading to luminal occlusion is a well-known complication of tracheostomy [2,9,10,18]. It is unknown if
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implementing change in these cold months such as increased frequency of saline bullets, ambient
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humidification, and use of heat-moisture exchanges may be of benefit. There remains a lack of standardization of important clinical factors regarding
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tracheostomy care and performance. The multidisciplinary team involved in the procedure, the
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postoperative care, and long-term maintenance results in a labyrinth of clinical care and the potential for suboptimal management. The time to tracheostomy in patients with prolonged intubation is important in preventing laryngeal complications from an endotracheal tube damaging the glottis and subglottis [19,20]. The Council on Critical Care of the American College of Chest Physicians recommends tracheostomy in patients who are expected to require mechanical ventilation for longer than 7 days. The final decision is made on an individual basis based on comorbidities and the patient’s current condition [21]. Additionally, the Belgium society of Pulmonology and Cardiothoracic Surgery have guidelines analogous to the guidelines
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in our institution including that tracheostomy should be performed at approximately day 7 if planning for mechanical ventilation for at least 14 days [10]. The decision for operative technique for placement of a tracheostomy includes analysis of multiple factors. Percutaneous tracheostomy is a safe alternative to the open technique when performed in appropriate patients [22,23]. The use of flaps or stay sutures has not been shown to decrease complications, yet there is selection bias in study since the most tenuous or complex
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airways often receive these secondary means of airway stabilization[24,25].
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The time to first tracheostomy tube change must strike a balance between allowing time
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for formation of a mature tract but changing early enough to prevent formation of biofilms,
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granulation tissue and prolonging hospitalization [19,26,27]. Patient factors such as body habitus, pulmonary status, and ease of surgical procedure often are considered when deciding
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when to change a tracheostomy tube for the first time. The most feared complication of airway
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loss can occur when a tube is changed prior to maturation of the stoma tract. Finally, with the many teams and trainees involved in tracheostomy care, education of
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those caring for patients with tracheostomies is crucial. Additionally, tracheostomy tube changes
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should be performed during daytime hours when more staff is available. A study by Tabaee et al. surveyed Otolaryngology training programs and reported that most tracheostomy tube changes were performed by junior residents and that 25% of tracheostomy tube changes occurred at night or weekends [28]. An educational program for all those who participate in tracheostomy care including nursing, respiratory therapy, surgical trainees, and speech therapy, should be paired with any quality improvement program to improve tracheostomy care.
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Some of the limitations of the study include a lack of long term follow up to assess complications and outcomes and complications after patients were discharged from the hospital. Additionally, the low major complication rate of 4.38% in the pre-intervention group and 2.74% in the post intervention group makes it difficult to demonstrate a significant difference between groups, even though their was a trend demonstrating improvement. Since this study was conducted at a single institution, it limits the heterogeneity of the providers managing these
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complex patients.
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CONCLUSION
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Tracheostomy peri-operative care standardization allows for improved tracking and measurement of clinical decision making and day-to-day care challenges. Improving
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measurement allows for appropriate systems interventions leading to iterations of quality
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improvement. As such, establishing a quality improvement team and systems based analyses of tracheostomy care has set a foundation for continued care assessment and quality of care. This
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model can potentially be used to improve care, decrease complications, and decrease costs
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associated with tracheostomies.
ACKNOWLEDGEMENTS: None
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Langley G, Moen R, Nolan K, Nolan T, Norman C, Provost L. The Improvement Guide: A
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Shah RK, Lander L, Berry JG, Nussenbaum B, Merati A, Roberson DW. Tracheotomy outcomes and complications: A national perspective. Laryngoscope. 2012;122(1):25-29.
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Das P, Zhu H, Shah RK, Roberson DW, Berry J, Skinner ML. Tracheotomy-related catastrophic events: Results of a national survey. Laryngoscope. 2012;122(1):30-37.
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Bn GS, Rb A, Saconato H, Án A, Valente O. Early versus late tracheostomy for critically
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tracheostomies include a Bjork flap? Laryngoscope. 2017;127(3):535-536. Lee SH, Kim KH, Woo SH. The usefulness of the stay suture technique in tracheostomy.
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Laryngoscope. 2015;125(6):1356-1359. Young D, Harrison D a, Cuthbertson BH, Rowan K. Effect of Early vs Late Tracheostomy. JAMA. 2013;309(20):2121-2129. 27.
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Tabaee A, Lando T, Rickert S, Stewart MG, Kuhel WI. Practice patterns, safety, and rationale for tracheostomy tube changes: A survey of otolaryngology training programs. Laryngoscope. 2007;117(4):573-576.
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First Tracheostomy Tube Change Checklist
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o Performed by the service which performed the surgical procedure o Occur between 6 AM and 6PM o Practitioner is competent in trach change/ management of inadvertent airway loss o Light source o Shoulder roll o Rigid suction o Flexible suction o New tracheostomy tube o Clinical team alerted (nurse, ICU team, respiratory therapist) o Procedure Note in Epic
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Table 2. Patient demographics before and after implementation of tracheostomy guidelines. Pre-intervention Post Intervention P-value Age 56.00(47.00-66.00) 61.00(52.00-71.00) 0.0628 Length of stay 17.00(10.00-32.00) 12.00(9.00-30.00) 0.1445 BMI 25.03(21.34-31.19) 26.60(23.09-30.80) 0.2291 First tracheostomy 5.00(4.00-7.00) 5.00(5.00-7.00) 0.9424 change (day) Sex Male 105(65.63) 39(53.42) Female 55(34.38) 34(46.58) 0.0754 Note: Continuous variables are reported as median (interquartile range) while categorical variables are reported as frequency (percent)
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Table 3. Clinical factors in tracheostomy care in patients undergoing tracheostomy before and after implementation of guidelines. Pre-Intervention Post-Intervention P-value Complication rate Major complication 7(4.38) 2(2.74) 0.0956 Minor complication 14(8.75) 10(13.70) No complication 139(86.88) 61(83.56) 0.4487 Indication Prolonged intubation 79(49.38) 24(32.88) Acute respiratory failure 8(5.00) 5(6.85) Neoplasm 63(39.38) 40(54.79) Trauma 10(6.25) 4(5.5) 0.105 Technique* Secondary stabilization 140(88.05) 57(79.17) No secondary stabilization 19(11.95) 15(20.83) 0.0775 Subspecialty Otolaryngology 110(68.75) 48(65.75) Oral maxillofacial surgery 20(12.50) 13(17.81) General surgery 30(18.75) 12(16.44) 0.5455 Note: Parentheses are percent values for all variables *Data for two subjects is not included in the post-intervention group due to omission in the medical record.
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Table 4. Contributing Factors to tracheostomy-related complications before and after implementation of guidelines for tracheostomy care Complication* no complication p-value Age 57.00(51.00-63.00) 58.00(47.50-67.00) 0.7139 Length of stay 20.00(12.00-32.00) 15.00(9.00-31.00) 0.1238 Length of intubation 11.50(9.00-14.00) 14.00(10.00-19.00) 0.1723 BMI Obese 11(33.33) 57(28.50) Overweight 7(21.21) 48(24.00) Normal weight 11(33.33) 81(40.50) Underweight 4(12.12) 14(7.00) 0.5958 Sex Male 20(60.61) 124(62.00) Female 13(39.39) 76(38.00) 0.8786 Indication Prolonged intubation 14(42.42) 89(44.50) ARF 2(6.06) 11(5.50) Neoplasm 14(42.42) 89(44.50) Trauma 3(9.09) 11(5.50) 0.8067 † Technique Secondary stabilization 25(78.13) 172(74.46) No secondary stabilization 7(21.88) 27(11.69) 0.2183 Subspecialty Otolaryngology 21(63.64) 137(68.50) Oral maxillofacial surgery 7(21.21) 26(13.00) General surgery 5(15.15) 37(18.50) 0.4440 Prior intubation Yes 14(42.42) 94(47.00) No 19(57.58) 105(53.00) 0.6253 Diabetes mellitus Yes 6(18.75) 34(17.26) No 26(81.25) 163(82.74) 0.8466 Cardiovascular disease Yes 5(15.63) 22(11.17) No 27(84.38) 175(88.83) 0.5521 Neurological disease Yes 1(3.13) 23(11.68) No 31(96.88) 174(88.32) 0.2142 Prior tobacco use Yes 9(28.13) 62(31.47) No 23(71.88) 135(68.53) 0.7042 ‡ Weather Hot 12(36.36) 112(56.00) Cold 21(63.64) 88(44.00) 0.0362
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Note: *Complication category includes both major and minor complications. †Secondary stabilization includes the use of stay sutures or a Bjork Flap whereas no Secondary stabilization includes an open tracheostomy or a percutaneous tracheostomy. Data for two subjects is not included due to omission in the medical record, both from the post-intervention group. ‡Hot weather includes the months April-September whereas Cold Weather includes the months October-March. Continuous variables are reported as median (interquartile range) while categorical variables are reported as frequency (percent)
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Figure 1. Gap analysis fishbone diagram identifying patient variables and clinical decisions that can contribute to reducing tracheostomy-related complications. Figure 2. Algorithm for determining the appropriate technique for tracheotomy.
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Figure 3. Tracheostomy complication rate post-intervention
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Figure 2
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Samuel J. Rubin, Stefanie S. Saunders, Jacob Kuperstock, Dominick Gadaleta, Peter A. Burke, Gregory Grillone, James M. Moses, Jaime P. Murphy, Gerardo Rodriguez, Andrew Salama, Michael P. Platt PII:
S0196-0709(19)31047-6
DOI:
https://doi.org/10.1016/j.amjoto.2019.102376
Reference:
YAJOT 102376
To appear in:
American Journal of Otolaryngology--Head and Neck Medicine and Surgery
Received date:
8 December 2019
Please cite this article as: S.J. Rubin, S.S. Saunders, J. Kuperstock, et al., Quality improvement in tracheostomy care: A multidisciplinary approach to standardizing tracheostomy care to reduce complications, American Journal of Otolaryngology--Head and Neck Medicine and Surgery(2019), https://doi.org/10.1016/j.amjoto.2019.102376
This is a PDF file of an article that has undergone enhancements after acceptance, such as the addition of a cover page and metadata, and formatting for readability, but it is not yet the definitive version of record. This version will undergo additional copyediting, typesetting and review before it is published in its final form, but we are providing this version to give early visibility of the article. Please note that, during the production process, errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.
© 2019 Published by Elsevier.
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Quality Improvement in Tracheostomy Care: A Multidisciplinary Approach to Standardizing Tracheostomy Care to Reduce Complications Samuel J. Rubin, MD, MPHa, [email protected] Stefanie S. Saunders, MD, MSca, [email protected] Jacob Kuperstock, MDa, [email protected]
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Dominick Gadaleta, MDa
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[email protected]
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Peter A. Burke, MDb [email protected]
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Gregory Grillone, MDa [email protected]
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Gerardo Rodriguez, MDe [email protected]
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Jaime P Murphy, MDd [email protected]
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James M. Moses, MD, MPHc [email protected]
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Andrew Salama, MD, DDSf [email protected] Michael P. Platt, MD, MSca [email protected] a
Department of Otolaryngology – Head and Neck Surgery, Boston University School of Medicine, Boston, Massachusetts, USA b
Department of General Surgery, Section of Trauma and Acute Care Surgery, Boston University School of Medicine, Boston, Massachusetts, USA c
Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts, USA
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d
Department of Pulmonary Medicine, Critical Care and Allergy, Boston University School of Medicine, Boston, Massachusetts, USA e
Department of Anesthesiology, Boston University School of Medicine, Boston, Massachusetts, USA f
Department of Oral & Maxillofacial Surgery, Henry M. Goldman School of Dental Medicine, Boston, Massachusetts, USA
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Corresponding Author: Michael P. Platt, MD, MSc, Department of Otolaryngology – Head and Neck Surgery, 800 Harrison Ave., BCD 5th floor, Boston, MA 20118, USA. Phone: 617-638-7669. Fax. 617-6387965 Email: [email protected]
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Presented at: Triological Society, Combined Otolaryngology Section Annual Meeting, Chicago, IL, May, 2016
Sources of Funding: None
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Conflicts of Interest: None
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Abstract Purpose: Develop a model for quality improvement in tracheostomy care and decrease tracheostomy-related complications. Methods: This study was a prospective quality improvement project at an academic tertiary care hospital. A multidisciplinary team was assembled to create institutional guidelines for clinical care during the pre-operative, intra-operative, and post-operative periods. Baseline data was
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compiled by retrospective chart review of 160 patients, and prospective tracking of select points
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over 8 months in 73 patients allowed for analysis of complications and clinical parameters.
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Results: Implementation of a quality improvement team was successful in creating guidelines,
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setting baseline parameters, and tracking data with run charts. Comparison of pre- and postguideline data showed a trend toward decreased rate of major complications from 4.38% to
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2.74% (p=0.096). Variables including time to tracheotomy for prolonged intubation, surgical
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technique, day of first tracheostomy tube change, and specialty performing surgery did not show
cold months (p=0.04).
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increased risk of complications. There were increased tracheostomy-related complications in
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Conclusions: An interdisciplinary quality improvement team can improve tracheostomy care by identifying system factors, standardizing care among specialties, and providing continuous monitoring of select data points.
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Introduction Tracheostomy is one of the most common surgical procedures performed in the United States annually with an average of approximately 100,000 cases performed per year or 34.3 cases per 100,000 US adults with an increase of 106% in the number of cases between 1993-2012 [1]. Tracheotomy is performed for multiple indications including: airway obstruction, prolonged intubation, airway malignancy, and copious secretions [2]. Those patients that require
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tracheostomy for prolonged intubation and mechanical ventilation have a significant economic
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effect on US healthcare spending with an estimated mean value of $306,135±$285467 per year
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per patient [3]. There are multiple surgical options and post-operative care decisions that impact
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both safety and cost-effectiveness of care for patients with tracheostomies with reported complication rates of 1.4%, 5.6%, and 7.1% for intraoperative, early, and late complications,
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respectively [4,5]. The appropriate care and maintenance of tube patency is crucial to avoiding
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serious complications, including infection, bleeding, accidental decannulation, and obstruction from granulation tissue formation or secretions [4]. The most serious tracheostomy-related
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complications can result in anoxic brain injury or death [6-8].
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Multiple teams and clinical factors contribute to tracheostomy placement decisions and care. With multiple specialties and surgeons performing and caring for tracheostomies, there is wide variation in clinical practice. There have been a limited number clinical guidelines published which describe the standard of care for management of patients with tracheostomy tubes [9,10]. Additionally, it is difficult to manage these complex tracheostomy patients without a multidisciplinary team including providers involved in all aspects of the patient’s care. These multidisciplinary teams have demonstrated decreased time to decannulation, decrease rate of adverse events, shorter lengths of stay in the ICU and reduced hospital length of stay [11-14].
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With a lack of consistency in tracheostomy care and metrics, limited publications on clinical guidelines, the high rate of morbidity and mortality, and the high cost to the healthcare system, standardizing care is of priority. The aim of this project was to standardize best practices at all stages of tracheostomy care: before, during, and after surgery, to decrease overall complications at a single institution. This was accomplished by development of comprehensive multidisciplinary clinical guidelines for tracheostomy care, implementation of tracheostomy
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education in all training programs who participate in care of patients with tracheostomy tubes,
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and development of instruments that can be used in clinical care to decrease complication rates.
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Methods Overview
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This study was designed as a quality improvement initiative at a single academic tertiary
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care hospital, and therefore was exempt from the Boston University School of Medicine Institutional Review Board approval. The plan-do-study-act (PDSA) cycle was employed, which
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is a methodology in Quality Improvement (QI) projects in health care to identify baseline data,
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plan change, and measure the change [15]. A retrospective chart review was performed to obtain baseline data. From that data guidelines were developed to implement change. Finally, multiple variables that were determined to be clinically important by the multi disciplinary team based on expert opinion and literature were then tracked to determine if implemented changes resulted in a decrease in complication rates. Secondary medically related factors were also identified and measured that were thought to contribute to complication rates.
Baseline Data Collection
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A retrospective chart review was performed that included all patients (n=160) who underwent tracheotomy at Boston Medical Center (BMC) over a 15 month period (June 1, 2012September 1, 2013). Patients were identified by searching inpatient ICD-9 procedure codes for the following: temporary tracheostomy (31.1), and other permanent tracheostomy (31.29). Baseline data was collected and recorded including patient age, sex, height, weight, body mass index (BMI), medical comorbidities, length of stay, indication for tracheostomy, days intubated
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prior to tracheostomy, technique used, first tracheostomy tube change post-operative day,
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tracheostomy related complications, and number of days in intensive care.
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Data was collected and maintained on an Excel (Microsoft Corp., Redmond, WA, USA)
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spreadsheet and saved on secure institutional networks. Indications for tracheostomy included prolonged intubation, acute respiratory failure, neoplasm, and trauma. Technique for
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tracheotomy included the use of secondary airway stabilization techniques such as a Bjork flap
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or stay sutures. Tracheostomy related complications were classified as either major or minor based on the expert opinion of the multidisciplinary team. All complications were identified
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during the initial hospital stay. Major complications included a loss of airway stability: false
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passage, desaturation requiring emergent resuscitation (code called), loss of airway, and hemorrhage requiring emergent intervention. Minor complications included tracheitis, pneumonia (developed after tracheostomy placement), mucus plugging, self-decannulation (without “code”), luminal occlusion (granulation), and minor bleeding without operative intervention. Intervention: Multidisciplinary Team and Guideline Development A multidisciplinary team was assembled to identify causes and contributing factors for tracheostomy-related complications, as well as develop an institutional consensus regarding the
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appropriate management of patients with tracheostomy tubes. All disciplines and specialties who are involved in tracheostomy tube care were included: Anesthesiology, General Surgery, Nursing, Nursing Education, Oral and Maxillofacial Surgery, Otolaryngology, Pulmonology, Quality Improvement / Safety, Respiratory Therapy, and Speech Pathology. Hospital-wide guidelines for tracheostomy care were then developed using baseline data, published reports, and expert opinion, for the preoperative, intraoperative, and postoperative
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periods. Guidelines were distributed to all departments and teams involved in all stages of
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tracheostomy care. Briefly, the guidelines recommend: 1. Performing tracheostomy within 14
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days for prolonged intubation (begin the process after 7 days of intubation); 2. The decision for
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tracheotomy technique (percutaneous, open, use of secondary means of stabilization) should consider patient factors (anatomy) and the risk of future airway loss (Figure 1); 3. The first
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tracheostomy tube change should be performed between day 5 and day 10 post-operatively by
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the team who performed the procedure. A checklist was created to assist in preparedness for the change (Table 1); 4. A multidisciplinary team should be involved in tracheostomy tube
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management including decisions for downsizing, use of speaking valve, capping trials, and
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decannulation.
A gap analysis was performed to identify causative factors in the care of patients with tracheostomy tubes that contribute to clinical variability and complications. Factors included were those associated with patient comorbidities, indications for tracheostomy, preoperative care, tracheostomy technique, postoperative care, and complications (Figure 2). These factors were selected based on published literature and the consensus and expert opinion of the multidisciplinary team.
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Plan-Do-Study-Act (PDSA) The selected clinical data points were tracked on a monthly basis over an 8-month period following guideline distribution and education (July 1, 2014- March 1, 2015). This was done for all new tracheostomy patients to determine if implemented changes resulted in decreased complication rates. All PDSA changes were implemented at once after the multidisciplinary meeting. The 14 clinical data points included: age, length of stay, length of intubation, BMI, sex,
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indication, technique, prior intubation, diabetes, cardiovascular disease, neurological disease,
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weather months included October to March.
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prior tobacco use, and weather. Hot weather months included April to September whereas cold
Data Analysis
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The primary clinical outcome for this project was tracheostomy complication rates before
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and after the implementation of a standardized tracheostomy management protocol. Additional data on comorbidities were also recorded. Statistical software SAS Version 9.3 (SAS Institute
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Inc., Cary, NC) was used for all statistical analysis. Mean and Standard deviation were recorded
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for all continuous variables, and frequencies and proportions were recorded for all categorical variables. Data was not assumed to be parametric. A test of variance was performed for all continuous data and a Kruskal-Wallis test was used to measure the difference between continuous variables. A chi-square test was used to compare the frequencies of all categorical variables. Multiple logistic regression analysis was performed to examine the association between tracheostomy complications, including both major and minor complications, and the predictor variables including obesity, hot (April-September) or cold (October- March) weather, the use of secondary stabilization methods when performing the tracheotomy procedure, and the
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first tracheostomy tube change at or before day 5 after initial procedure. All data with an alpha level < 0.05 was determined to be significant.
Results Baseline (pre-intervention) data was collected for 160 tracheostomy patients over 1 year. Of the included patients, 105 were males (65.6%) and 55 were females (34.4%) with a mean age
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of 54.8 years. Tracheostomies were performed for prolonged intubation (49.4%), neoplasm
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(39.4%), trauma (6.2%), and acute respiratory failure (5%). Secondary stabilization techniques
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with Bjork flap or stay sutures were performed in 87.5% of cases based on surgeon preference.
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There were no complications in the majority of patients (86.88%). Major complications were recorded in 4.38%, and minor complications were recorded in 8.75% of patients (Tables 2,3).
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Tracheostomies were prospectively tracked monthly over an 8-month period following
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guideline development, distribution, and education (n=73). Similar demographics were again recorded as in the pre-intervention group. Of these patients, 39 were male (53.4%), 34 were
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female (46.6%) with a mean age of 58.4 years. Tracheostomies were performed for prolonged
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intubation (32.9%), neoplasm (54.8%), trauma (5.5%), and acute respiratory failure (6.8%). The overall complication rate was 16.4%, with major complications seen in 2.7% of patients, and minor complications in 13.7% of patients. (Tables 1, 2)(Figure 3). Additionally, the major complication rate pre-intervention was 4.38% and the major complication rate post-intervention was 2.74%. This was an overall reduction by 71.4% (p=0.096). Factors contributing to complications before and after intervention were reported. There was no significant difference in 13 of the 14 variables (Table 4). The only factor associated with complications in tracheostomy management was the time of year and associated climate in
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Boston, Massachusetts (p=0.034). In the logistic regression analysis, there was a significant association between tracheostomy complications and weather at time of complication after controlling for obesity, the use of secondary stabilization methods, and first tracheostomy tube change before at or before day 5. Patients that underwent tracheotomy in the cold months of the year (October-March) have 2.49 times the odds of having a complications compared to patients
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that underwent tracheotomy in the hot months of the year (95%CI (1.111, 5.584); p=0.027).
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Discussion
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This study describes the process of developing a multidisciplinary tracheostomy
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management protocol and implementing this protocol in a single institution with its associated outcomes. A variety of factors were investigated in an attempt to standardize tracheostomy care
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across specialties and caregivers by obtaining baseline metrics that could be tracked overtime to
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assess change. In determining the baseline data, areas of potential improvement were identified via multidisciplinary team discussion, and guidelines were developed to standardize care. Using
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change.
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the PDSA cycle model, clinical points were identified and successfully tracked to measure
Major and minor complications of tracheostomy are well documented and various studies have reported an incidence of 3.8% to 97% in open tracheotomies [16]. Shah et al reported an overall complication rate of 3.2%, and a mortality rate of 19.2% in 113,653 tracheostomies that were performed nationally in 2012 [17]. Das et al estimate 1000 catastrophic events annually, 500 of which lead to death or permanent disability [18]. There is no doubt that the frequency of tracheostomy complications and potential for catastrophic complications necessitate quality improvement methods for improving care in patients with tracheostomy tubes.
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In this quality improvement project, the major complication rate was 4.38% in the preintervention group and 2.74% in the post-intervention group. These rates are similar to those reported in the literature. Since major complications are a less common occurrence at a single institution, a larger sample size, possibly via a multicenter study, are needed to obtain higher power. The finding that patients who underwent tracheotomy in the cold months of the year
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(October-March) have 2.49 times the odds of having a complications compared to patients that
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underwent tracheotomy in the hot months of the year (95%CI (1.111, 5.584); p=0.0267) has not
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been previously reported. This may be a seasonal component due to dry indoor heat in the cold
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months leading to tracheitis, bleeding, and mucous plugging. Mucus plugging leading to luminal occlusion is a well-known complication of tracheostomy [2,9,10,18]. It is unknown if
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implementing change in these cold months such as increased frequency of saline bullets, ambient
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humidification, and use of heat-moisture exchanges may be of benefit. There remains a lack of standardization of important clinical factors regarding
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tracheostomy care and performance. The multidisciplinary team involved in the procedure, the
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postoperative care, and long-term maintenance results in a labyrinth of clinical care and the potential for suboptimal management. The time to tracheostomy in patients with prolonged intubation is important in preventing laryngeal complications from an endotracheal tube damaging the glottis and subglottis [19,20]. The Council on Critical Care of the American College of Chest Physicians recommends tracheostomy in patients who are expected to require mechanical ventilation for longer than 7 days. The final decision is made on an individual basis based on comorbidities and the patient’s current condition [21]. Additionally, the Belgium society of Pulmonology and Cardiothoracic Surgery have guidelines analogous to the guidelines
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in our institution including that tracheostomy should be performed at approximately day 7 if planning for mechanical ventilation for at least 14 days [10]. The decision for operative technique for placement of a tracheostomy includes analysis of multiple factors. Percutaneous tracheostomy is a safe alternative to the open technique when performed in appropriate patients [22,23]. The use of flaps or stay sutures has not been shown to decrease complications, yet there is selection bias in study since the most tenuous or complex
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airways often receive these secondary means of airway stabilization[24,25].
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The time to first tracheostomy tube change must strike a balance between allowing time
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for formation of a mature tract but changing early enough to prevent formation of biofilms,
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granulation tissue and prolonging hospitalization [19,26,27]. Patient factors such as body habitus, pulmonary status, and ease of surgical procedure often are considered when deciding
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when to change a tracheostomy tube for the first time. The most feared complication of airway
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loss can occur when a tube is changed prior to maturation of the stoma tract. Finally, with the many teams and trainees involved in tracheostomy care, education of
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those caring for patients with tracheostomies is crucial. Additionally, tracheostomy tube changes
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should be performed during daytime hours when more staff is available. A study by Tabaee et al. surveyed Otolaryngology training programs and reported that most tracheostomy tube changes were performed by junior residents and that 25% of tracheostomy tube changes occurred at night or weekends [28]. An educational program for all those who participate in tracheostomy care including nursing, respiratory therapy, surgical trainees, and speech therapy, should be paired with any quality improvement program to improve tracheostomy care.
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Some of the limitations of the study include a lack of long term follow up to assess complications and outcomes and complications after patients were discharged from the hospital. Additionally, the low major complication rate of 4.38% in the pre-intervention group and 2.74% in the post intervention group makes it difficult to demonstrate a significant difference between groups, even though their was a trend demonstrating improvement. Since this study was conducted at a single institution, it limits the heterogeneity of the providers managing these
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complex patients.
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CONCLUSION
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Tracheostomy peri-operative care standardization allows for improved tracking and measurement of clinical decision making and day-to-day care challenges. Improving
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measurement allows for appropriate systems interventions leading to iterations of quality
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improvement. As such, establishing a quality improvement team and systems based analyses of tracheostomy care has set a foundation for continued care assessment and quality of care. This
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model can potentially be used to improve care, decrease complications, and decrease costs
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associated with tracheostomies.
ACKNOWLEDGEMENTS: None
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Langley G, Moen R, Nolan K, Nolan T, Norman C, Provost L. The Improvement Guide: A
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Shah RK, Lander L, Berry JG, Nussenbaum B, Merati A, Roberson DW. Tracheotomy outcomes and complications: A national perspective. Laryngoscope. 2012;122(1):25-29.
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Das P, Zhu H, Shah RK, Roberson DW, Berry J, Skinner ML. Tracheotomy-related catastrophic events: Results of a national survey. Laryngoscope. 2012;122(1):30-37.
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Bn GS, Rb A, Saconato H, Án A, Valente O. Early versus late tracheostomy for critically
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tracheostomies include a Bjork flap? Laryngoscope. 2017;127(3):535-536. Lee SH, Kim KH, Woo SH. The usefulness of the stay suture technique in tracheostomy.
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Laryngoscope. 2015;125(6):1356-1359. Young D, Harrison D a, Cuthbertson BH, Rowan K. Effect of Early vs Late Tracheostomy. JAMA. 2013;309(20):2121-2129. 27.
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Tabaee A, Lando T, Rickert S, Stewart MG, Kuhel WI. Practice patterns, safety, and rationale for tracheostomy tube changes: A survey of otolaryngology training programs. Laryngoscope. 2007;117(4):573-576.
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First Tracheostomy Tube Change Checklist
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o Performed by the service which performed the surgical procedure o Occur between 6 AM and 6PM o Practitioner is competent in trach change/ management of inadvertent airway loss o Light source o Shoulder roll o Rigid suction o Flexible suction o New tracheostomy tube o Clinical team alerted (nurse, ICU team, respiratory therapist) o Procedure Note in Epic
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Table 2. Patient demographics before and after implementation of tracheostomy guidelines. Pre-intervention Post Intervention P-value Age 56.00(47.00-66.00) 61.00(52.00-71.00) 0.0628 Length of stay 17.00(10.00-32.00) 12.00(9.00-30.00) 0.1445 BMI 25.03(21.34-31.19) 26.60(23.09-30.80) 0.2291 First tracheostomy 5.00(4.00-7.00) 5.00(5.00-7.00) 0.9424 change (day) Sex Male 105(65.63) 39(53.42) Female 55(34.38) 34(46.58) 0.0754 Note: Continuous variables are reported as median (interquartile range) while categorical variables are reported as frequency (percent)
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Table 3. Clinical factors in tracheostomy care in patients undergoing tracheostomy before and after implementation of guidelines. Pre-Intervention Post-Intervention P-value Complication rate Major complication 7(4.38) 2(2.74) 0.0956 Minor complication 14(8.75) 10(13.70) No complication 139(86.88) 61(83.56) 0.4487 Indication Prolonged intubation 79(49.38) 24(32.88) Acute respiratory failure 8(5.00) 5(6.85) Neoplasm 63(39.38) 40(54.79) Trauma 10(6.25) 4(5.5) 0.105 Technique* Secondary stabilization 140(88.05) 57(79.17) No secondary stabilization 19(11.95) 15(20.83) 0.0775 Subspecialty Otolaryngology 110(68.75) 48(65.75) Oral maxillofacial surgery 20(12.50) 13(17.81) General surgery 30(18.75) 12(16.44) 0.5455 Note: Parentheses are percent values for all variables *Data for two subjects is not included in the post-intervention group due to omission in the medical record.
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Table 4. Contributing Factors to tracheostomy-related complications before and after implementation of guidelines for tracheostomy care Complication* no complication p-value Age 57.00(51.00-63.00) 58.00(47.50-67.00) 0.7139 Length of stay 20.00(12.00-32.00) 15.00(9.00-31.00) 0.1238 Length of intubation 11.50(9.00-14.00) 14.00(10.00-19.00) 0.1723 BMI Obese 11(33.33) 57(28.50) Overweight 7(21.21) 48(24.00) Normal weight 11(33.33) 81(40.50) Underweight 4(12.12) 14(7.00) 0.5958 Sex Male 20(60.61) 124(62.00) Female 13(39.39) 76(38.00) 0.8786 Indication Prolonged intubation 14(42.42) 89(44.50) ARF 2(6.06) 11(5.50) Neoplasm 14(42.42) 89(44.50) Trauma 3(9.09) 11(5.50) 0.8067 † Technique Secondary stabilization 25(78.13) 172(74.46) No secondary stabilization 7(21.88) 27(11.69) 0.2183 Subspecialty Otolaryngology 21(63.64) 137(68.50) Oral maxillofacial surgery 7(21.21) 26(13.00) General surgery 5(15.15) 37(18.50) 0.4440 Prior intubation Yes 14(42.42) 94(47.00) No 19(57.58) 105(53.00) 0.6253 Diabetes mellitus Yes 6(18.75) 34(17.26) No 26(81.25) 163(82.74) 0.8466 Cardiovascular disease Yes 5(15.63) 22(11.17) No 27(84.38) 175(88.83) 0.5521 Neurological disease Yes 1(3.13) 23(11.68) No 31(96.88) 174(88.32) 0.2142 Prior tobacco use Yes 9(28.13) 62(31.47) No 23(71.88) 135(68.53) 0.7042 ‡ Weather Hot 12(36.36) 112(56.00) Cold 21(63.64) 88(44.00) 0.0362
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Note: *Complication category includes both major and minor complications. †Secondary stabilization includes the use of stay sutures or a Bjork Flap whereas no Secondary stabilization includes an open tracheostomy or a percutaneous tracheostomy. Data for two subjects is not included due to omission in the medical record, both from the post-intervention group. ‡Hot weather includes the months April-September whereas Cold Weather includes the months October-March. Continuous variables are reported as median (interquartile range) while categorical variables are reported as frequency (percent)
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Figure 1. Gap analysis fishbone diagram identifying patient variables and clinical decisions that can contribute to reducing tracheostomy-related complications. Figure 2. Algorithm for determining the appropriate technique for tracheotomy.
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Figure 3. Tracheostomy complication rate post-intervention
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