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Late Outcome From Percutaneous Tracheostomy Using the Portex Kit
clinical investigations in critical care Late Outcome From Percutaneous Tracheostomy Using the Portex Kit* Richard C. Leonard, MB BChir; Richard H. Lewis, MB BS; Bhajan Singh, MB BS; and P. Vernon van Heerden, MB BCh, FCCP
Objective: To assess late outcome following percutaneous tracheostomy using the Portex kit (Hythe, Kent, UK). Design: Prospective observational cohort study. Setting: Teaching hospital. Patients: Forty-nine consecutive patients who underwent percutaneous tracheostomy in the ICU using the Portex kit and who survived 6 months after the procedure. Interventions: Questionnaires regarding six symptoms were sent to all 49 surviving patients; the 39 respondents were invited to attend for review. Thirteen patients underwent pulmonary function testing, of whom 10 also underwent fiberoptic laryngotracheoscopy under local anesthesia. Results: The most common symptom was a minor change in voice. One patient had required treatment for symptomatic tracheal stenosis by the time of review; one was referred for revision of a tethered scar. Pulmonary function testing was easily performed by all patients and revealed no evidence of upper airway obstruction. Tracheoscopy likewise showed no evidence of tracheal stenosis. Conclusions: One of 49 patients had developed tracheal stenosis. None of the patients attending for detailed review showed any sign of late complications other than one tethered scar. (CHEST 1999; 115:1070 –1075) Key words: tracheal stenosis; tracheostomy, percutaneous dilational Abbreviations: APACHE 5 acute physiology and chronic health evaluation; FIF50 5 forced inspiratory flow at 50% of vital capacity
advantages and low early complication T heratepractical of percutaneous tracheostomy have led to its widespread application in the ICU. Two techniques are in common use today. The Ciaglia method,1 marketed For related material see page 915 in kit form (Cook Critical Care; Bloomington, IN), requires serial dilators to be passed over a guidewire *From the Departments of Intensive Care (Drs. Leonard and van Heerden), Otolaryngology (Dr. Lewis), and Pulmonary Physiology (Dr. Singh), Sir Charles Gairdner Hospital, Perth, Australia. Manuscript received April 22, 1998; revision accepted October 13, 1998. Correspondence to: Richard C. Leonard, MB BChir, Sir Charles Gairdner Hospital, Department of Intensive Care, Verdun Street, Nedlands, Perth, Western Australia 6009, Australia; e-mail: richard [email protected] 1070
inserted percutaneously into the trachea. The technique described by Griggs et al2 and marketed by Portex (Portex; Hythe, Kent, UK) uses a dilating forceps introduced over the guidewire to form the stoma. The few studies examining long-term outcome from percutaneous tracheostomy are confined to the Ciaglia method. We describe the review of ICU survivors using a questionnaire, pulmonary function testing, and flexible tracheoscopy a minimum of 6 months after they underwent percutaneous tracheostomy with the Portex technique. Materials and Methods This ICU admits approximately 1,400 medical and surgical patients each year from a tertiary hospital with a full range of specialties, including active neurosurgical, cardiothoracic surgical, and emergency departments. The hospital is one of three Clinical Investigations in Critical Care
referral centers for a population of approximately 1.7 million people. Between January 1995 and May 1996, 80 patients underwent percutaneous tracheostomy using the Portex kit in the ICU. At the time of follow-up, at least 6 months after operation, 54 patients had survived. Institutional ethics committee approval was obtained. Questionnaires were then sent to all surviving patients except those known to be neurologically too disabled to complete them; a total of 49 patients were contacted. The questionnaires asked patients to grade six symptoms as either absent (score 5 0), mild (score 5 1), or severe (score 5 2). The symptoms were pain, change in voice, shortness of breath, stridor, cough, and cosmetic appearance of scar. Responders were then invited to attend for further review, which included assessment of the scar by the investigators as either good (no or minimal visible scar; score 5 0), satisfactory (visible but neat scar; score 5 1), or poor (obvious and ugly scar, including skin tethering; score 5 2). Written informed consent was obtained at the beginning of this review. Patients then underwent formal pulmonary function testing and flexible tracheoscopy. Upper airway function was assessed in 13 patients by inspiratory and expiratory flow-volume loops. These were obtained by a dedicated technician using a digital pneumotachograph (model 47303 A; Hewlett Packard; Waltham, MA) and procedures conforming to the recommendations of the American Thoracic Society.3 The flow-volume loops were evaluated by a pulmonary physiologist blinded to all other findings for evidence of upper airway obstruction using the criteria of Rotman et al.4 These are as follows: (1) forced inspiratory flow at 50% of vital capacity (FIF50) # 100 L/min; (2) ratio of forced expiratory flow at 50% of vital capacity to the FIF50 (FEF50:FIF50) $ 1; (3) ratio of the FEV1 (mL) to peak expiratory flow rate (L/min) (FEV1: PEFR) $ 10 mL/min/L; and (4) ratio of the FEV1 to the expired volume in 0.5 s (FEV1:FEV0.5) $ 1.5. Tracheoscopy was performed on 10 patients under topical anesthesia using nebulized lidocaine. The appearance of the tracheal lumen was graded as good (minimal or no visible scar; score 5 0), moderate (lesions producing , 10% luminal obstruction; score 5 1), or poor (lesions producing . 10% luminal obstruction; score 5 2).
Results Questionnaires Thirty-nine patients returned the questionnaires; 19 were female and 20 were male, aged between 16 and 86 years (mean, 52 years). APACHE (acute physiology and chronic health evaluation) II scores ranged from 2 to 33 (mean, 16). Scores for each symptom are shown in Table 1. Total scores for each patient ranged from 0 to 7 (mean, 1.6). Two patients still had a tracheostomy in situ. Their records were reviewed. One of these had upper airway obstruction due to bilateral vocal cord paralysis, which was the indication for tracheostomy; she has since been decannulated successfully. The other was an 82-year-old woman who was admitted with severe lactic acidosis due to metformin therapy, complicated by acute renal failure and nosocomial pneumonia. Translaryngeal intubation was needed
Table 1—Questionnaire Results* Score Symptom
0
1
2
Mean Score
Pain Voice change Dyspnea Stridor Cough Scar
37 18 32 31 29 27
0 13 2 6 6 8
0 6 3 0 2 2
0 0.68 0.22 0.16 0.27 0.32
*Number of patients with each score, by symptom (excluding those with tracheostomy still in situ).
for a total of 14 days before percutaneous tracheostomy was performed. During that time, she failed two trials of extubation owing to severe glottic edema and stridor, and she required reintubation on each occasion. The tracheostomy was decannulated after 18 days. She presented 5 months later with subglottic stenosis due to posterior and lateral granulation tissue, which was managed with a surgical tracheostomy in view of her advanced age. She has since been successfully decannulated without undergoing any other treatment. Review of Scar Thirteen patients attended for review; 5 were female and 8 were male, aged between 18 and 76 years (mean, 52 years). APACHE II scores ranged from 6 to 33 (mean, 15). The interval between tracheostomy and review was between 8 and 16 months (mean, 12 months). Duration of translaryngeal intubation prior to percutaneous tracheostomy was between 4 and 16 days (mean, 10.5 days). Investigators assessed all scars with one exception as either good or satisfactory. Mean score was 0.31. One patient with a tethered scar was referred for plastic surgical revision. Inspiratory and Expiratory Flow Volume Loops Technically satisfactory flow-volume loops were obtained from all 13 patients. None showed upper airway obstruction. Tracheoscopy Eleven patients consented to undergo flexible tracheoscopy; one was unable to tolerate the procedure. Of the remaining 10 patients, 3 were female and 7 were male, aged between 18 and 68 years (mean, 48 years). APACHE II scores ranged from 6 to 33 (mean, 16). Admission diagnoses for this group were as follows: coronary artery bypass grafting CHEST / 115 / 4 / APRIL, 1999
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(two); aortic valve replacement; head injury (three); chest trauma; pneumonia; septic shock; and Japanese B encephalitis. No patient had significant abnormality of the tracheal lumen (all scored 0). In most cases, only minimal scarring was apparent; in some, no scar at all could be seen.
Discussion So far as we are aware, there are no published data examining long-term outcome from percutaneous tracheostomy using the Portex kit. Our results, while far from conclusive in view of the small sample size, are encouraging. Of 49 ICU survivors, only 1 had sustained a serious complication requiring treatment. This patient had already had severe problems with upper airway obstruction due to glottic edema prior to tracheostomy, so (as discussed below) it may not be correct to attribute the subglottic stenosis to the procedure. We found no evidence of tracheal stenosis or, by pulmonary function testing, of tracheomalacia in any of the patients who attended for review. Moreover, the questionnaires revealed a very low incidence of symptoms. Change in voice was the most commonly reported symptom (19 of 39 patients, or 48.7%, with a mean score of 0.68). Whether this was due to the technique of tracheostomy or to the preceding intubation is not discernible from our data. We included a functional assessment of the upper airway using flow-volume loops in order to detect both the fixed obstruction of tracheal stenosis and the variable obstruction produced by tracheomalacia. When performed by trained technicians, the test was easy for the patients to comply with. It is not possible to comment on its ability to detect asymptomatic stenoses, since no such lesions were found at tracheoscopy. Clearly the small size of our sample limits its power to detect complications, and larger studies are necessary. However, the 39 patients who returned the questionnaires represent almost half of those undergoing the procedure over a period of 18 months. To recruit much larger numbers of cases will entail acquisition of data over long periods of time or from multiple centers, with the attendant possibility of confounding variations in practice. We believe the 10 patients who underwent complete assessment are likely to be representative of the population as a whole. Although selection bias cannot be excluded, the low level of symptoms among those completing the questionnaire makes the presence of significant undetected abnormalities unlikely. Moreover, the geographically concentrated and isolated nature of medical practice in Western 1072
Australia means that we would almost certainly have learned of any other complications through informal channels. The technique for surgical tracheostomy was formalized in 1909 by Chevalier Jackson Sr.5 In 1921, Jackson6 published his hugely influential article deploring cricothyroidotomy and high tracheostomy, based on a very high incidence of subglottic stenosis following injury to the cricoid cartilage in such an approach. The accepted level of stoma formation became the second and third tracheal rings. Stomata formed below this level carry an increased risk of tracheoinnominate fistulae.7,8 Higher approaches retained their ill repute until Brantigan and Grow9 challenged Jackson’s view with a series of 655 elective cricothyroidotomies with an extremely low complication rate. Despite occasional reports during the 1950s and 1960s,10 –12 percutaneous tracheostomy only achieved widespread use after Ciaglia et al,1 influenced by Brantigan and Grow,9 described their technique in 1985. In this method, a 14G catheterover-needle cannula is inserted into the trachea at the level of the first tracheal ring; initially the space between the cricoid cartilage and the first tracheal ring was used, but the technique has been modified to use the space between the first and second rings. Recent authors advocate the use of either this or the next space inferiorly.13 The needle is then withdrawn and a guidewire introduced, followed by a series of dilators of increasing size until the stoma permits the passage of a normal-sized tracheostomy tube. A kit designed for this method is marketed by Cook. Reception of the Ciaglia technique has been favorable, with a number of case series showing early complication rates that compare well with those for surgical tracheostomy.1,14 –24 At least eight studies have been published comparing the Ciaglia technique with surgical tracheostomy; two are retrospective,25,26 two are prospective but unrandomized,27,28 and four are both prospective and randomized.29 –32 Five studies reported improved outcome with the Ciaglia tracheostomy in terms of reduced bleeding and stomal infection,25,26,28 –30 while three recorded few complications of note with either method.27,31,32 Interestingly, one of the studies showing the most convincing benefit from the percutaneous approach came not from an ICU, but from the University of Zurich Department of Otorhinolaryngology.28 These authors found a significantly lower incidence of both bleeding (2.1% vs 13.9%; p , 0.05) and infection (0% vs 22.2%; p , 0.001) comparing Ciaglia percutaneous tracheostomy with the surgical technique. A potential refinement of the Ciaglia technique has been the use of dilating forceps placed over the guidewire to create the stoma. Early versions of this Clinical Investigations in Critical Care
were not uniformly successful; despite a report of minimal complications in 61 patients,33 others described serious problems.34 However, the equipment described by Griggs et al2 and marketed by Portex has performed well in early assessments,35,36 including one large prospective but unrandomized study showing improved early outcome compared with surgical tracheostomy.37 The Portex kit contains a modified Howard-Kelly forceps that is passed over the guidewire and opened to form the stoma. The advantages of the percutaneous methods in obviating the need for surgical referral and the transfer of patients in an unstable condition to the operating theater, coupled with the comparative rarity of bleeding or infective complications, have led to their increasing use in ICU patients requiring elective tracheostomy. This development has not been greeted with universal enthusiasm; some have cautioned against unreserved adoption of the technique until long-term outcome has also been shown to be comparable to the surgical approach.7,38 Long-term complications of tracheostomy by any method include tracheal stenosis, tracheomalacia and fistula formation between the trachea and either the esophagus or the innominate artery, the first two being the main focus of attention. Stenosis may occur in the subglottic region following injury to the cricoid cartilage, or at the level of either the stoma or the cuff. It usually presents 1 to 2 months following decannulation, but occasionally symptoms appear much later.39 The reported incidence of tracheal stenosis following surgical tracheostomy varies widely: figures of 0%,40,41 0.5%,42 5%,43 8%,44,45 10%,46 14%,47 33%,48 65%,49,50 and 96%51 are quoted depending on the method used to assess outcome. Most studies using symptomatic stenosis requiring treatment as the end point give an incidence of around 5 to 15%.43– 47 Few of these studies are recent, and the current incidence of tracheal stenosis after surgical tracheostomy in the ICU population is likely to be lower. Reasons for this include the introduction of high-volume low-pressure cuffs39 and cuff pressure monitoring, reducing the incidence of cuff-level stenoses. End points other than symptomatic stenosis have also been used to assess outcome; these include MRI,52 tomography,39,51,53 tracheoscopy,45 and pulmonary function testing.54 The variation regarding end points is compounded by the difficulty of attributing tracheal stenosis to the tracheostomy rather than the often prolonged translaryngeal intubation that precedes it. This is particularly so for subglottic stenosis, as there is evidence that translaryngeal intubation may injure the posterior cricoid.55 Stauffer et al49 reported a 19% incidence of subglottic stenosis following prolonged translaryngeal intubation. They also found that the
combination of prolonged translaryngeal intubation followed by tracheostomy is particularly liable to produce tracheal stenosis. Thus, in our case of posterior subglottic stenosis, it is highly probable that the problem was due to the translaryngeal intubation rather than to the tracheostomy. Studies examining long-term outcome after percutaneous tracheostomy are few and are confined to the Ciaglia technique. Ciaglia and Graniero16 reported on 52 patients evaluated solely by clinical assessment in whom they observed no complications. The same group has subsequently reported on a larger series of 254 patients, of whom 2 developed tracheal stenosis, though the number of patients available for long-term follow-up was not given.15 Hill et al21 followed up 214 patients decannulated after Ciaglia tracheostomy, and found that 8 (3.7%) developed symptomatic tracheal stenosis. Twentyeight of the 65 patients studied by Cobean et al20 were followed up in the long term by clinical assessment alone; 1 developed glottic stenosis. The study by Fischler et al56 used clinical evaluation in 16 patients and fiberoptic laryngotracheoscopy in 10 of these. No significant tracheal lesions were found. Van Heurn et al53 assessed 54 asymptomatic patients using tomography and found that 14 (26%) had tracheal stenosis of . 10%. Law et al38 evaluated 41 patients with clinical interviews, fiberoptic laryngotracheoscopy, and pulmonary function testing. No patients were symptomatic but four had tracheoscopic stenoses of between 10% and 40%. They commented that pulmonary function testing was difficult for many patients to comply with. The Zurich group followed up 33 patients with either surgical or Ciaglia tracheostomies after decannulation and found clinical evidence of tracheal stenosis in none.28 McFarlane et al57 reported four cases of tracheal stenosis following Ciaglia tracheostomy. They speculated that the dilators had forced pretracheal tissue into the tracheal lumen and that this may have led to the stenoses. Their hypothesis may be supported by the postmortem findings of van Heurn et al58 of tracheal ring fractures in 11 of 12 patients who died after (but not because of) Ciaglia tracheostomy. Moreover, one of the present authors has observed skin tissue within the tracheal lumen when closing a tracheocutaneous fistula following a Ciaglia tracheostomy. Certainly, considerable force can be needed to pass the serial dilators, while the Portex kit may be inherently less prone to such problems. However, all of the patients of McFarlane et al57 had required reintubation for upper airway obstruction following initial extubation before they underwent tracheostomy, so it seems far from clear that the procedure was responsible for the problem. CHEST / 115 / 4 / APRIL, 1999
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The long-term outcome following percutaneous tracheostomy using either method should ideally be compared in randomized trials with surgical tracheostomy, but there may already be a sufficient groundswell of opinion in favor of the percutaneous approach to make this difficult. In any case, the comparative rarity of complications means that large numbers of patients need to be studied, and it remains to be clarified by what method and what end points outcome is best assessed. Tracheoscopy is invasive and it may be difficult to obtain sufficient patient numbers. Certainly our group seemed markedly less willing (or able) to attend for follow-up than others.38 Pulmonary function testing has been criticized by Law et al38 both as insensitive in that it failed to detect asymptomatic lesions seen at tracheoscopy, and as hard for patients to perform. However, the significance of asymptomatic tracheoscopic lesions is unclear, and pulmonary function testing may provide a repeatable measure of airway obstruction in symptomatic patients. Moreover, our patients found no difficulty in complying with the test. It seems likely, however, that the most useful end point in large-scale studies will prove to be tracheal stenosis requiring surgery or preventing decannulation. The available data suggest that there is little difference between surgical and percutaneous tracheostomies in terms of late complications. The present study indicates that the Portex tracheostomy kit is also comparable to existing techniques. Pending large-scale studies, it is therefore reasonable to continue the present widespread practice of using both percutaneous and surgical methods, with uncomplicated cases receiving the advantages of the percutaneous approach and surgical referral being reserved for patients in whom technical difficulty is anticipated. In conclusion, there was one case of subglottic stenosis in 49 patients who underwent percutaneous tracheostomy with the Portex kit, and one patient with a tethered scar. We found no evidence of tracheal stenosis or tracheomalacia in the patients who attended for detailed review. ACKNOWLEDGMENTS: We thank Dr. K. Finucane and the staff of the Department of Pulmonary Physiology, Sir Charles Gairdner Hospital, for carrying out pulmonary function testing, and Ms. B. Roberts for organizational assistance and data collection.
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Objective: To assess late outcome following percutaneous tracheostomy using the Portex kit (Hythe, Kent, UK). Design: Prospective observational cohort study. Setting: Teaching hospital. Patients: Forty-nine consecutive patients who underwent percutaneous tracheostomy in the ICU using the Portex kit and who survived 6 months after the procedure. Interventions: Questionnaires regarding six symptoms were sent to all 49 surviving patients; the 39 respondents were invited to attend for review. Thirteen patients underwent pulmonary function testing, of whom 10 also underwent fiberoptic laryngotracheoscopy under local anesthesia. Results: The most common symptom was a minor change in voice. One patient had required treatment for symptomatic tracheal stenosis by the time of review; one was referred for revision of a tethered scar. Pulmonary function testing was easily performed by all patients and revealed no evidence of upper airway obstruction. Tracheoscopy likewise showed no evidence of tracheal stenosis. Conclusions: One of 49 patients had developed tracheal stenosis. None of the patients attending for detailed review showed any sign of late complications other than one tethered scar. (CHEST 1999; 115:1070 –1075) Key words: tracheal stenosis; tracheostomy, percutaneous dilational Abbreviations: APACHE 5 acute physiology and chronic health evaluation; FIF50 5 forced inspiratory flow at 50% of vital capacity
advantages and low early complication T heratepractical of percutaneous tracheostomy have led to its widespread application in the ICU. Two techniques are in common use today. The Ciaglia method,1 marketed For related material see page 915 in kit form (Cook Critical Care; Bloomington, IN), requires serial dilators to be passed over a guidewire *From the Departments of Intensive Care (Drs. Leonard and van Heerden), Otolaryngology (Dr. Lewis), and Pulmonary Physiology (Dr. Singh), Sir Charles Gairdner Hospital, Perth, Australia. Manuscript received April 22, 1998; revision accepted October 13, 1998. Correspondence to: Richard C. Leonard, MB BChir, Sir Charles Gairdner Hospital, Department of Intensive Care, Verdun Street, Nedlands, Perth, Western Australia 6009, Australia; e-mail: richard [email protected] 1070
inserted percutaneously into the trachea. The technique described by Griggs et al2 and marketed by Portex (Portex; Hythe, Kent, UK) uses a dilating forceps introduced over the guidewire to form the stoma. The few studies examining long-term outcome from percutaneous tracheostomy are confined to the Ciaglia method. We describe the review of ICU survivors using a questionnaire, pulmonary function testing, and flexible tracheoscopy a minimum of 6 months after they underwent percutaneous tracheostomy with the Portex technique. Materials and Methods This ICU admits approximately 1,400 medical and surgical patients each year from a tertiary hospital with a full range of specialties, including active neurosurgical, cardiothoracic surgical, and emergency departments. The hospital is one of three Clinical Investigations in Critical Care
referral centers for a population of approximately 1.7 million people. Between January 1995 and May 1996, 80 patients underwent percutaneous tracheostomy using the Portex kit in the ICU. At the time of follow-up, at least 6 months after operation, 54 patients had survived. Institutional ethics committee approval was obtained. Questionnaires were then sent to all surviving patients except those known to be neurologically too disabled to complete them; a total of 49 patients were contacted. The questionnaires asked patients to grade six symptoms as either absent (score 5 0), mild (score 5 1), or severe (score 5 2). The symptoms were pain, change in voice, shortness of breath, stridor, cough, and cosmetic appearance of scar. Responders were then invited to attend for further review, which included assessment of the scar by the investigators as either good (no or minimal visible scar; score 5 0), satisfactory (visible but neat scar; score 5 1), or poor (obvious and ugly scar, including skin tethering; score 5 2). Written informed consent was obtained at the beginning of this review. Patients then underwent formal pulmonary function testing and flexible tracheoscopy. Upper airway function was assessed in 13 patients by inspiratory and expiratory flow-volume loops. These were obtained by a dedicated technician using a digital pneumotachograph (model 47303 A; Hewlett Packard; Waltham, MA) and procedures conforming to the recommendations of the American Thoracic Society.3 The flow-volume loops were evaluated by a pulmonary physiologist blinded to all other findings for evidence of upper airway obstruction using the criteria of Rotman et al.4 These are as follows: (1) forced inspiratory flow at 50% of vital capacity (FIF50) # 100 L/min; (2) ratio of forced expiratory flow at 50% of vital capacity to the FIF50 (FEF50:FIF50) $ 1; (3) ratio of the FEV1 (mL) to peak expiratory flow rate (L/min) (FEV1: PEFR) $ 10 mL/min/L; and (4) ratio of the FEV1 to the expired volume in 0.5 s (FEV1:FEV0.5) $ 1.5. Tracheoscopy was performed on 10 patients under topical anesthesia using nebulized lidocaine. The appearance of the tracheal lumen was graded as good (minimal or no visible scar; score 5 0), moderate (lesions producing , 10% luminal obstruction; score 5 1), or poor (lesions producing . 10% luminal obstruction; score 5 2).
Results Questionnaires Thirty-nine patients returned the questionnaires; 19 were female and 20 were male, aged between 16 and 86 years (mean, 52 years). APACHE (acute physiology and chronic health evaluation) II scores ranged from 2 to 33 (mean, 16). Scores for each symptom are shown in Table 1. Total scores for each patient ranged from 0 to 7 (mean, 1.6). Two patients still had a tracheostomy in situ. Their records were reviewed. One of these had upper airway obstruction due to bilateral vocal cord paralysis, which was the indication for tracheostomy; she has since been decannulated successfully. The other was an 82-year-old woman who was admitted with severe lactic acidosis due to metformin therapy, complicated by acute renal failure and nosocomial pneumonia. Translaryngeal intubation was needed
Table 1—Questionnaire Results* Score Symptom
0
1
2
Mean Score
Pain Voice change Dyspnea Stridor Cough Scar
37 18 32 31 29 27
0 13 2 6 6 8
0 6 3 0 2 2
0 0.68 0.22 0.16 0.27 0.32
*Number of patients with each score, by symptom (excluding those with tracheostomy still in situ).
for a total of 14 days before percutaneous tracheostomy was performed. During that time, she failed two trials of extubation owing to severe glottic edema and stridor, and she required reintubation on each occasion. The tracheostomy was decannulated after 18 days. She presented 5 months later with subglottic stenosis due to posterior and lateral granulation tissue, which was managed with a surgical tracheostomy in view of her advanced age. She has since been successfully decannulated without undergoing any other treatment. Review of Scar Thirteen patients attended for review; 5 were female and 8 were male, aged between 18 and 76 years (mean, 52 years). APACHE II scores ranged from 6 to 33 (mean, 15). The interval between tracheostomy and review was between 8 and 16 months (mean, 12 months). Duration of translaryngeal intubation prior to percutaneous tracheostomy was between 4 and 16 days (mean, 10.5 days). Investigators assessed all scars with one exception as either good or satisfactory. Mean score was 0.31. One patient with a tethered scar was referred for plastic surgical revision. Inspiratory and Expiratory Flow Volume Loops Technically satisfactory flow-volume loops were obtained from all 13 patients. None showed upper airway obstruction. Tracheoscopy Eleven patients consented to undergo flexible tracheoscopy; one was unable to tolerate the procedure. Of the remaining 10 patients, 3 were female and 7 were male, aged between 18 and 68 years (mean, 48 years). APACHE II scores ranged from 6 to 33 (mean, 16). Admission diagnoses for this group were as follows: coronary artery bypass grafting CHEST / 115 / 4 / APRIL, 1999
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(two); aortic valve replacement; head injury (three); chest trauma; pneumonia; septic shock; and Japanese B encephalitis. No patient had significant abnormality of the tracheal lumen (all scored 0). In most cases, only minimal scarring was apparent; in some, no scar at all could be seen.
Discussion So far as we are aware, there are no published data examining long-term outcome from percutaneous tracheostomy using the Portex kit. Our results, while far from conclusive in view of the small sample size, are encouraging. Of 49 ICU survivors, only 1 had sustained a serious complication requiring treatment. This patient had already had severe problems with upper airway obstruction due to glottic edema prior to tracheostomy, so (as discussed below) it may not be correct to attribute the subglottic stenosis to the procedure. We found no evidence of tracheal stenosis or, by pulmonary function testing, of tracheomalacia in any of the patients who attended for review. Moreover, the questionnaires revealed a very low incidence of symptoms. Change in voice was the most commonly reported symptom (19 of 39 patients, or 48.7%, with a mean score of 0.68). Whether this was due to the technique of tracheostomy or to the preceding intubation is not discernible from our data. We included a functional assessment of the upper airway using flow-volume loops in order to detect both the fixed obstruction of tracheal stenosis and the variable obstruction produced by tracheomalacia. When performed by trained technicians, the test was easy for the patients to comply with. It is not possible to comment on its ability to detect asymptomatic stenoses, since no such lesions were found at tracheoscopy. Clearly the small size of our sample limits its power to detect complications, and larger studies are necessary. However, the 39 patients who returned the questionnaires represent almost half of those undergoing the procedure over a period of 18 months. To recruit much larger numbers of cases will entail acquisition of data over long periods of time or from multiple centers, with the attendant possibility of confounding variations in practice. We believe the 10 patients who underwent complete assessment are likely to be representative of the population as a whole. Although selection bias cannot be excluded, the low level of symptoms among those completing the questionnaire makes the presence of significant undetected abnormalities unlikely. Moreover, the geographically concentrated and isolated nature of medical practice in Western 1072
Australia means that we would almost certainly have learned of any other complications through informal channels. The technique for surgical tracheostomy was formalized in 1909 by Chevalier Jackson Sr.5 In 1921, Jackson6 published his hugely influential article deploring cricothyroidotomy and high tracheostomy, based on a very high incidence of subglottic stenosis following injury to the cricoid cartilage in such an approach. The accepted level of stoma formation became the second and third tracheal rings. Stomata formed below this level carry an increased risk of tracheoinnominate fistulae.7,8 Higher approaches retained their ill repute until Brantigan and Grow9 challenged Jackson’s view with a series of 655 elective cricothyroidotomies with an extremely low complication rate. Despite occasional reports during the 1950s and 1960s,10 –12 percutaneous tracheostomy only achieved widespread use after Ciaglia et al,1 influenced by Brantigan and Grow,9 described their technique in 1985. In this method, a 14G catheterover-needle cannula is inserted into the trachea at the level of the first tracheal ring; initially the space between the cricoid cartilage and the first tracheal ring was used, but the technique has been modified to use the space between the first and second rings. Recent authors advocate the use of either this or the next space inferiorly.13 The needle is then withdrawn and a guidewire introduced, followed by a series of dilators of increasing size until the stoma permits the passage of a normal-sized tracheostomy tube. A kit designed for this method is marketed by Cook. Reception of the Ciaglia technique has been favorable, with a number of case series showing early complication rates that compare well with those for surgical tracheostomy.1,14 –24 At least eight studies have been published comparing the Ciaglia technique with surgical tracheostomy; two are retrospective,25,26 two are prospective but unrandomized,27,28 and four are both prospective and randomized.29 –32 Five studies reported improved outcome with the Ciaglia tracheostomy in terms of reduced bleeding and stomal infection,25,26,28 –30 while three recorded few complications of note with either method.27,31,32 Interestingly, one of the studies showing the most convincing benefit from the percutaneous approach came not from an ICU, but from the University of Zurich Department of Otorhinolaryngology.28 These authors found a significantly lower incidence of both bleeding (2.1% vs 13.9%; p , 0.05) and infection (0% vs 22.2%; p , 0.001) comparing Ciaglia percutaneous tracheostomy with the surgical technique. A potential refinement of the Ciaglia technique has been the use of dilating forceps placed over the guidewire to create the stoma. Early versions of this Clinical Investigations in Critical Care
were not uniformly successful; despite a report of minimal complications in 61 patients,33 others described serious problems.34 However, the equipment described by Griggs et al2 and marketed by Portex has performed well in early assessments,35,36 including one large prospective but unrandomized study showing improved early outcome compared with surgical tracheostomy.37 The Portex kit contains a modified Howard-Kelly forceps that is passed over the guidewire and opened to form the stoma. The advantages of the percutaneous methods in obviating the need for surgical referral and the transfer of patients in an unstable condition to the operating theater, coupled with the comparative rarity of bleeding or infective complications, have led to their increasing use in ICU patients requiring elective tracheostomy. This development has not been greeted with universal enthusiasm; some have cautioned against unreserved adoption of the technique until long-term outcome has also been shown to be comparable to the surgical approach.7,38 Long-term complications of tracheostomy by any method include tracheal stenosis, tracheomalacia and fistula formation between the trachea and either the esophagus or the innominate artery, the first two being the main focus of attention. Stenosis may occur in the subglottic region following injury to the cricoid cartilage, or at the level of either the stoma or the cuff. It usually presents 1 to 2 months following decannulation, but occasionally symptoms appear much later.39 The reported incidence of tracheal stenosis following surgical tracheostomy varies widely: figures of 0%,40,41 0.5%,42 5%,43 8%,44,45 10%,46 14%,47 33%,48 65%,49,50 and 96%51 are quoted depending on the method used to assess outcome. Most studies using symptomatic stenosis requiring treatment as the end point give an incidence of around 5 to 15%.43– 47 Few of these studies are recent, and the current incidence of tracheal stenosis after surgical tracheostomy in the ICU population is likely to be lower. Reasons for this include the introduction of high-volume low-pressure cuffs39 and cuff pressure monitoring, reducing the incidence of cuff-level stenoses. End points other than symptomatic stenosis have also been used to assess outcome; these include MRI,52 tomography,39,51,53 tracheoscopy,45 and pulmonary function testing.54 The variation regarding end points is compounded by the difficulty of attributing tracheal stenosis to the tracheostomy rather than the often prolonged translaryngeal intubation that precedes it. This is particularly so for subglottic stenosis, as there is evidence that translaryngeal intubation may injure the posterior cricoid.55 Stauffer et al49 reported a 19% incidence of subglottic stenosis following prolonged translaryngeal intubation. They also found that the
combination of prolonged translaryngeal intubation followed by tracheostomy is particularly liable to produce tracheal stenosis. Thus, in our case of posterior subglottic stenosis, it is highly probable that the problem was due to the translaryngeal intubation rather than to the tracheostomy. Studies examining long-term outcome after percutaneous tracheostomy are few and are confined to the Ciaglia technique. Ciaglia and Graniero16 reported on 52 patients evaluated solely by clinical assessment in whom they observed no complications. The same group has subsequently reported on a larger series of 254 patients, of whom 2 developed tracheal stenosis, though the number of patients available for long-term follow-up was not given.15 Hill et al21 followed up 214 patients decannulated after Ciaglia tracheostomy, and found that 8 (3.7%) developed symptomatic tracheal stenosis. Twentyeight of the 65 patients studied by Cobean et al20 were followed up in the long term by clinical assessment alone; 1 developed glottic stenosis. The study by Fischler et al56 used clinical evaluation in 16 patients and fiberoptic laryngotracheoscopy in 10 of these. No significant tracheal lesions were found. Van Heurn et al53 assessed 54 asymptomatic patients using tomography and found that 14 (26%) had tracheal stenosis of . 10%. Law et al38 evaluated 41 patients with clinical interviews, fiberoptic laryngotracheoscopy, and pulmonary function testing. No patients were symptomatic but four had tracheoscopic stenoses of between 10% and 40%. They commented that pulmonary function testing was difficult for many patients to comply with. The Zurich group followed up 33 patients with either surgical or Ciaglia tracheostomies after decannulation and found clinical evidence of tracheal stenosis in none.28 McFarlane et al57 reported four cases of tracheal stenosis following Ciaglia tracheostomy. They speculated that the dilators had forced pretracheal tissue into the tracheal lumen and that this may have led to the stenoses. Their hypothesis may be supported by the postmortem findings of van Heurn et al58 of tracheal ring fractures in 11 of 12 patients who died after (but not because of) Ciaglia tracheostomy. Moreover, one of the present authors has observed skin tissue within the tracheal lumen when closing a tracheocutaneous fistula following a Ciaglia tracheostomy. Certainly, considerable force can be needed to pass the serial dilators, while the Portex kit may be inherently less prone to such problems. However, all of the patients of McFarlane et al57 had required reintubation for upper airway obstruction following initial extubation before they underwent tracheostomy, so it seems far from clear that the procedure was responsible for the problem. CHEST / 115 / 4 / APRIL, 1999
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The long-term outcome following percutaneous tracheostomy using either method should ideally be compared in randomized trials with surgical tracheostomy, but there may already be a sufficient groundswell of opinion in favor of the percutaneous approach to make this difficult. In any case, the comparative rarity of complications means that large numbers of patients need to be studied, and it remains to be clarified by what method and what end points outcome is best assessed. Tracheoscopy is invasive and it may be difficult to obtain sufficient patient numbers. Certainly our group seemed markedly less willing (or able) to attend for follow-up than others.38 Pulmonary function testing has been criticized by Law et al38 both as insensitive in that it failed to detect asymptomatic lesions seen at tracheoscopy, and as hard for patients to perform. However, the significance of asymptomatic tracheoscopic lesions is unclear, and pulmonary function testing may provide a repeatable measure of airway obstruction in symptomatic patients. Moreover, our patients found no difficulty in complying with the test. It seems likely, however, that the most useful end point in large-scale studies will prove to be tracheal stenosis requiring surgery or preventing decannulation. The available data suggest that there is little difference between surgical and percutaneous tracheostomies in terms of late complications. The present study indicates that the Portex tracheostomy kit is also comparable to existing techniques. Pending large-scale studies, it is therefore reasonable to continue the present widespread practice of using both percutaneous and surgical methods, with uncomplicated cases receiving the advantages of the percutaneous approach and surgical referral being reserved for patients in whom technical difficulty is anticipated. In conclusion, there was one case of subglottic stenosis in 49 patients who underwent percutaneous tracheostomy with the Portex kit, and one patient with a tethered scar. We found no evidence of tracheal stenosis or tracheomalacia in the patients who attended for detailed review. ACKNOWLEDGMENTS: We thank Dr. K. Finucane and the staff of the Department of Pulmonary Physiology, Sir Charles Gairdner Hospital, for carrying out pulmonary function testing, and Ms. B. Roberts for organizational assistance and data collection.
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