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Peripheral IV Stabilization and the Rate of Complications in Children: An Exploratory Study
Journal of Pediatric Nursing (2014) xx, xxx–xxx
Peripheral IV Stabilization and the Rate of Complications in Children: An Exploratory Study1,2 Nikki Laudenbach MSN,RN a , Carie A. Braun PhD b,⁎, Leigh Klaverkamp BSN,RN a , Sigrid Hedman-Dennis MS,CNS b a
St. Cloud Hospital, St. Cloud, MN Department of Nursing, College of St. Benedict/St. John's University, St. Joseph, MN
b
Received 28 October 2013; revised 4 February 2014; accepted 4 February 2014
Key words: Children; Intravenous; Stabilization; Complications
Peripheral intravascular catheter insertion is the most common invasive procedure performed on the hospitalized child with a significant potential for complications. This study compared complication rates between a standard aseptic taping technique and a commercially-available adhesive anchoring device in 80 hospitalized children ages 2–17 years. Eighteen (18) participants (22.5%) experienced a complication with occlusion being the most common (n = 8) followed by infiltration (n = 4), leaking (n = 3), and dislodgement (n = 2). There were no differences in complication rates or types between the two groups. This study provides evidence that a stabilization device may not be necessary in shortduration PIVs in children. © 2014 Elsevier Inc. All rights reserved.
THE INSERTION OF a peripheral intravascular (PIV) access device is one of the most common invasive procedures performed on hospitalized children. However, the placement of a PIV access device increases the risk for the development of phlebitis, infection, infiltration, and extravasation. Children are particularly vulnerable to these PIV-induced complications. In one surveillance report, neonates were impacted by these complications at nearly twice the rate of adults, particularly in critical care areas (O'Grady et al., 2011). In other studies, PIV complications were reported at rates as high as 28% in children (Garland et al., 1992; Pettit, 2003) compared to 8.5% in adults (Flippo & Lee, 2011) leading to prolonged hospitalization, increased medical costs, higher mortality, and greater morbidity in both groups (McCullen & Pieper, 2006; Pearson, 1996; White, 2001).
1 This research was supported by a faculty development and research grant from the College of St. Benedict/St. John's University. 2 The authors of this manuscript are not affiliated in any way with the intravenous stabilization product used in this study. ⁎ Corresponding author: Carie A. Braun, PhD. E-mail address: [email protected].
0882-5963/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.pedn.2014.02.002
The cause of PIV complications has most often been attributed to bacterial colonization and unintended catheter movement. Inadequate hand hygiene, lack of aseptic technique, and prolonged indwell time, maintained at 72 hours and beyond, has been consistently associated with increased incidence of phlebitis and infection (Powell, Tarnow, & Perucca, 2008; Tripathi, Kaushik, & Singh, 2008). In one study, over 50% of children experienced infiltration or phlebitis after 96 hours of PIV placement (Tripathi et al., 2008). In addition, small veins, the inability to verbalize or localize discomfort, underdeveloped immunity, and uncontrolled movement are developmental characteristics of young children contributing to the loss of PIV patency and the subsequent onset of complications (Cornely, Berthe, Pauls, & Waldschmidt, 2002; Doellman et al., 2009; Lee et al., 2009; Maki & Ringer, 1991; McCullen & Pieper, 2006). Since the 1990s, there has been growing interest in the use of commercially-available adhesive devices to stabilize PIV catheters in adults. In most studies, complication rates were reduced dramatically compared to stabilization using tape, gauze, or sutures (Moureau & Iannucci, 2003; Royer, 2003; Runyan et al., 2011; Schears, 2006; Sheppard, LeDesma,
2 Morris, & O’Connor, 1999; Wood, 1997; Wood & BoweGeddes, 1997; Yamamoto et al., 2002) with few exceptions (Bausone-Gazda, Lefaiver, & Walters, 2010). Additionally, Flippo and Lee (2011) evaluated the clinical effectiveness of the Sorbaview SHIELD, a sterile adhesive, with a particular interest in cost reduction. The authors reported a change in practice from StatLock to the new Sorbaview SHIELD and a direct cost savings of $120,000/year. Yet even with this change, unscheduled restarts reached 8.5% due to dislodgement, leaking, occlusion, or infiltration, well above the goal of b 5% recommended by the Infusion Nurses Society (2006). More recently, research on adhesive anchoring devices have been conducted in the pediatric population with mixed results. Pondinas (2008) determined no difference in the longevity of the PIV catheter compared to securement with a sterile transparent dressing, however, there was a statistically significant reduction in complications with the children in which the stabilization device was used. Heltz (2009) found complication rates were higher in PIVs for children where StatLock was used alone (43%) compared to a control group (35%) and those with a combination of House UltraDressing and StatLock (15%). Also, the StatLock Pediatric device was rated as difficult to use by almost half of the nurses, especially for “small” children and those less than 8 years of age (Heltz, 2009). In 2011, the Infusion Nurses Society recommended sufficient stabilization of PIV catheters, with preference given to manufactured adhesive anchoring devices (Infusion Nurses Society, 2011). In the same year, guidelines published in the American Journal of Infection Control also recommended sutureless securement devices to reduce the risk of infection with intravascular catheters (O'Grady et al., 2011). This standard was based on suggestive evidence for effectiveness comparing sutures to StatLock in PICC lines in adults (Yamamoto et al., 2002). The universality of this recommendation, however, has not been established in either adults or children, and the routine use of such devices has not yet permeated nursing practice. The purpose of this study was to explore PIV securement and stabilization and the resulting PIV complications by comparing a standard sterile transparent dressing and the StatLock securement device in children (StatLock® IV Select Pediatric Stabilization Device, Venetec International Inc./Bard Access Systems, Salt Lake City, Utah).
N. Laudenbach et al. the child was between 2–17 years of age, and the parent/ guardian consented to participation. Participants admitted to the pediatric unit with a PIV already in place were excluded from the study as well as those with a known adhesive allergy or those with a PIV insertion angle, such as the antecubital or scalp veins, that were not conducive to the use of the StatLock Pediatric stabilization device. Also, children under 2 years of age were excluded due to the challenges of securing the StatLock stabilization device to small surface areas of their extremities. Thirty-seven (37) participants were required in each of the taping method and StatLock stabilization device groups based on power = .80, 2-tailed test with alpha = .05 assuming a 19.005% predicted difference in complication rates between the two groups (Kraemer & Thiemann, 1987). This was a conservative estimate as similar studies reported complication rate reductions in excess of 30% (Royer, 2003). Training on human subject and study procedures commenced for nursing staff and research assistants using a training video, return demonstration, and an instructional poster placed centrally on the pediatric unit. Parents/ Guardians and patients were approached directly by the staff nurses in conjunction with the principal investigators or trained co-investigators to inquire about interest in study participation and to determine eligibility. Following the consent and assent process, children were placed into the intervention or control group by alternating eligible participants (the first eligible participant was placed in the control group; the second was in the intervention group, etc.). A study packet was placed on the nurses' station with instructions on the study protocol, consent and assent forms, and data collection sheets. Data were collected between July 2010 and August 2012. The study was approved by the facility's institutional review board. In the control group, each PIV was inserted and maintained in accordance with the pediatric unit policies and procedures utilizing a 3 M Tegaderm™ IV 1610, an arm
Method The study was conducted at a 489-bed midwestern regional medical center with a 20-bed pediatric unit. The sample location was selected due to accessibility of children in the desired age range and access to children who required PIV insertion. Participants were enrolled if the following conditions were met: a PIV catheter placement was needed,
Figure 1 and tape.
Method for securing with a sterile transparent dressing
Comparison on Peripheral IV Stabilization board, 1 inch 3 M tape, and 3 inch 3 M tape for securement. The final product is shown in Figure 1. For the intervention group, policies and procedures were also upheld with the addition of the StatLock stabilization device. The supplies utilized for stabilization with the StatLock came prepackaged and included an adhesive strip, the StatLock device, and transparent dressing. This is shown in Figure 2. Peripheral IVs were then observed for both the control and intervention groups until removal. Complications were defined as evidence of phlebitis (inflammation of a vein), extravasation (rupture of the vein after administration of a harsh IV solution), infiltration (inadvertent administration of a solution/medication into surrounding tissue) and/or other unexpected reasons for removal, such as occlusion, leaking, or dislodgement.
Results Data were entered into SPSS (19.0) and analyzed using descriptive and inferential statistics. Statistical significance was determined at p ≤ .05. Descriptive statistics were applied to categorical and continuous variables to obtain information about the overall sample and each group with regard to age, sex, PIV indwell time in hours, PIV fluid type and rate in mL/hr, PIV location, medications administered through the PIV, the reason for removal, and the type of complications, if any. Inferential statistics compared the differences in outcome for the two groups, via chi square or t test for independent groups, to determine statistical significance between each variable and the influence on peripheral IV complications.
3 The final convenience sample consisted of 80 children: 36 used StatLock and 44 were in the standard taping group. The smaller StatLock group was a result of significant missing data (n = 3) or parent acceptance to participate in the study only if the standard taping method was used (n = 5). There were no statistically significant differences between the two groups with regard to demographic variables. The mean age of participants was 7.94 years of age. There were 31 males and 47 females with an average PIV catheter indwell time of 37.98 hours. Among the entire sample, the most common placement site was the left hand (n = 39) followed by the right hand (n = 22) and then the left forearm (n = 5). Of the 69 participants on medications, most were on multiple IV medications (n = 25) followed by singular antibiotics (n = 22), opiate analgesics (n = 7) and antiemetics (n = 7). Seventy-three (73) of the participants had PIV fluids administered during the study with the most common solutions being D5 + ½ NS + KCL 20 mEq/L (n = 53) followed by normal saline (n = 5) at an average of 58.36 mL/hr. The most common reason for removal was completion of IV therapy (n = 53) followed by presence of a complication requiring restart (n = 16) and then by accidental removal by patient or complication not requiring a restart (n = 11). Among the sample, 18 out of 80 participants (22.5%) experienced some type of PIV complication with occlusion being the most common complication (n = 8) followed by infiltration (n = 4), leaking (n = 3), and dislodgement (n = 2). The two groups were almost identical in the type of complication experienced by each. Chi square statistics were applied to determine any statistically significant difference between the two groups. There were no differences in complication rates between the taping and StatLock groups (p = .957). These results are summarized in Table 1. Additionally, chi square statistics were applied to categorical variables to determine any statistically significant difference between those who experienced a PIV complication and those who did not, separate of stabilization procedure. There were no differences in complication rates for females compared to males (p = .118). Similarly, when adding stabilization as a variable, there were no differences among males and females in complication rates by taping Table 1 Complication rates comparing taping and StatLock Groups. StatLock stabilization (n = 36)
Figure 2 device.
Method for securing with a StatLock ® stabilization
Taping stabilization (n = 44)
No complications 28 (77.8%) 34 (77.3%) Complications-total 8 (22.7%) 10 (22.5%) Complications-by type Infiltration = 2 Infiltration = 2 Phlebitis = 1 Phlebitis = 0 Occlusion = 3 Occlusion = 5 Dislodgement = 1 Dislodgement = 1 Leaking = 1 Leaking = 2
4
N. Laudenbach et al. Table 2
Administration of medications and complication rates between the taping and StatLock Groups. StatLock
0 meds 1 med 2 + meds Total
Total
+ Complications, n (%)
− Complications, n (%)
6 (23.1%) 4 (50.0%) 3 (37.5%)
1 (12.5%) 14 (53.8%) 6 (23.1%)
Taping
7 (20.6%) 18 (52.9%) 9 (26.5%) p = .660
Total
+ Complications, n (%)
− Complications, n (%)
1 (8.8%) 4 (44.4%) 4 (44.4%)
3 (11.1%) 19 (55.9%) 12 (35.3%)
4 (9.3%) 23 (53.5%) 16 (37.2%) p = .829
*Statistical significance = p ≤ .05.
method (p = .114) versus StatLock stabilization (p = .562). The only categorical variable that appeared to be trending toward statistical significance on first glance was the number of medications administered and complication rates among the two groups (Table 2). More participants in the StatLock group appeared to have a greater rate of complications when no medications were administered as well as when one or multiple medications were administered through the PIV site, although this was not confirmed statistically. The overall statistical significance between the StatLock and taping groups was p = .683. Independent samples t tests were then applied with respect to the presence or absence of complications to compare differences in age (p = .891), PIV catheter indwell time (p = .144), and PIV fluid rate (p = .717). The longer indwell times and rate of complications in the StatLock group is visually larger and longer in duration but did not reach statistical significance. Due to a smaller sample size comparing the stabilization devices and complications, a Mann–Whitney U test was conducted to verify statistical power. The mean rank difference was also not statistically significant between the StatLock and taping groups (U = 30.00, p = .374, r = − .889) for those with and without complications (Table 3). In summary, there were virtually no differences between the standard taping method and the StatLock group with regard to PIV complications.
Discussion This study contributes to the evidence regarding stabilization of PIVs and the resulting rate of complications in children. The hypothesis that children will have a significant fewer PIV complications with the StatLock device was not Table 3
supported in this sample. In addition, no other study variables impacted the rate of complications and neither securement procedure was effective in reducing the complication rate below 5% (Infusion Nurses Society, 2006). The interest in reducing complication rates through improved PIV stabilization continues to be an important but challenging endeavor. Despite research reports on successes gained through stabilization of PIVs, complication rates remain extraordinarily high (Callaghan, Copnell, & Johnston, 2002; Machado, Pedreira, & Chaud, 2008; Royer, 2003; Schears, 2006; Sheppard et al., 1999; Wood & Bowe-Geddes, 1997) demonstrated by post-intervention complication rates ranging from 36–52% in control groups and 14%–36% in intervention groups. Several explanations for the results have been considered. Stabilization with a transparent dressing and tape and the commercially-available anchoring adhesive device may be equally effective in short-duration PIVs. In this study, PIV indwell times averaged just over 1 1/2 days. The shortened time with the PIV in place could impact the value of stabilization products. For PIVs with a longer indwell time, securement may play a larger role. Smith (2006) noted that the 96-hour indwell survival rate for PIVs was 52% for StatLock compared to 8% for non-sterile tape securement. This is certainly a consideration when PIVs must be maintained for greater than 96 hours. Other reports have also indicated greater success when securing tubing that can more easily become unstable, such as PICCs, urinary catheters, chest tubes, or peritoneal dialysis catheters (Weber & Sparks, 2005; Wood & Bowe-Geddes, 1997). Conclusive evidence on best practices for PIV insertion and maintenance appears limited to frequent assessment, strictly aseptic insertion technique, and the use of an arm board splint, in children where uncontrolled movement is expected (Bierman, 2003; Center for Disease Control and
Comparing complication rates based on age and indwell time. p Value ⁎
StatLock
Age (in years) Indwell time (in hours)
+ Complications (n = 8) M (SD)
− Complications (n = 28) M (SD)
8.88 (6.96) 61.33 (64.08)
9.61 (5.15) 31.23 (22.04)
⁎ Statistical significance = p ≤ .05.
.744 .230
p Value ⁎
Taping + Complications (n = 10) M (SD)
− Complications (n = 34) M (SD)
6.90 (5.63) 54.65 (77.35)
6.65 (5.39) 32.92 (22.67)
.897 .402
Comparison on Peripheral IV Stabilization Prevention, 2002; Kulkarni, 2001). Cochrane collaborative groups have found no evidence for changing catheters every 72–96 hours (Webster et al., 2013), insufficient support for heparin use in neonates to prolong catheter patency (Shah, Ng, & Sinha, 2009), and insufficient evidence to support intermittent versus continuous flushing of catheters (Flint, McIntosh, & Davies, 2009). In a few studies, nursing staff engagement and education do appear to have an impact on PIV success (Boyd et al., 2011; Hetzler et al., 2011; Lopez et al., 2004; Tofani et al., 2012), but the persistence of behavior change through educational interventions is unknown. The study is limited by a convenience sample at one facility and cannot be generalized to the population. Also, the StatLock was not appropriate for children under 2 years of age and in certain PIV locations with a small surface area. The decision not to explore cost comparisons and potential cost savings was also a limitation of this study. Not surprisingly, few studies on PIV catheter securement are randomized or otherwise fit the criteria for rigorous clinical trials (Alekseyev et al., 2012). Yet researchers and practitioners must continue to search for the best evidence to reduce PIV complications across all populations, particularly children. Future research should therefore consider other causative variables contributing to short-duration PIV complications and potential cost controls in randomized clinical trials in an effort to eliminate PIV complications entirely.
References Alekseyev, S., Byrne, M., Carpenter, A., Franker, C., Kidd, & Hulton, L. (2012). Prolonging the life of a patient’s IV: An integrative review of intravenous stabilization devices. MedSurg Nursing, 21, 285–292. Bausone-Gazda, D., Lefaiver, C., & Walters, S. (2010). A randomized control trial to compare the complications of 2 peripheral intravenous catheter-stabilization systems. Journal of Infusion Nursing, 33, 371–384. Bierman, S. (2003). Tape: A dirty business. Infection Control Today, 7, 4–7. Boyd, S., Aggarwal, I., Davey, P., Logan, M., & Nathwani, D. (2011). Peripheral intravenous catheters: The road to quality improvement and safer patient care. Journal of Hospital Infection, 77, 34–41. Callaghan, S., Copnell, B., & Johnston, L. (2002). Comparison of two methods of peripheral intravenous cannula securement in the pediatric setting. Journal of Infusion Nursing, 25, 256–264. Centers for Disease Control and Prevention. (2010). Guidelines for the prevention of intravascular catheter-related infections. MMWR, 51, 16. Cornely, O., Berthe, U., Pauls, R., & Waldschmidt, D. (2002). Peripheral Teflon catheters: Factors determining the incidence of phlebitis and duration of cannulation. Infection Control and Hospital Epidemiology, 23, 249–254. Doellman, D., Hadaway, L., Bowe-Geddes, L., Franklin, M., LeDonne, J., Papke-O'Donnell, L., Pettit, J., Schulmeister, L., & Stranz, M. (2009). Infiltration and extravasation: Update on prevention and management. Journal of Infusion Nursing, 32, 203–211. Flint, A., McIntosh, D., & Davies, M. (2009). Continuous infusion versus intermittent flushing to prevent loss of function of intravenous catheters used for drug administration in newborn infants. Cochrane Database of Systematic Reviews, http://dx.doi.org/10.1002/14651858.CD004593 Art. No: CD004593.
5 Flippo, P., & Lee, J. (2011). Clinical evaluation of the Sorbaview SHIELD securement device used on peripheral intravenous catheters in the acute care setting. The Journal of Association for Vascular Access, 16, 95–102. Garland, J., Dunne, M., Havens, P., Hintermeyer, M., Bozzette, M., Wincek, J., Bromberger, T., & Seavers, M. (1992). Peripheral intravenous catheter complications in critically ill children: A prospective study. Pediatrics, 89, 1145–1150. Heltz, C. (2009). Improving peripheral IV safety by maximizing ability to assess and secure lines. Poster session presented at the meeting of the Society of Pediatric Nurses, http://dx.doi.org/10.1016/j.pedn.2008.11.033. Hetzler, R., Wilson, M., Hill, E. K., & Hollenback, C. (2011). Securing pediatric peripheral IV catheters: Application of an evidence-based practice model. Journal of Pediatric Nursing, 26, 143–148. Infusion Nurses Society. (2006). Infusion nursing standards of practice. Journal of Infusion Nursing, 29, S58–S60. Infusion Nurses Society. (2011). Infusion nursing standards of practice. Journal of Infusion Nursing, 54, S46–S47. Kraemer, H., & Thiemann, S. (1987). How many subjects? Statistical power analysis in research. Newbury Park, CA: Sage Publications, Inc. Kulkarni, K. (2001). Vascular complication of hand, filling of facial spaces of hand and hand sepsis following intravenous infusions. Acad Today, 9–11. Lee, W., Chen, H., Tsai, T., Lai, I., Chang, W., Huang, C., & Fang, C. (2009). Risk factors for peripheral intravenous catheter infection in hospitalized patients: A prospective study of 3165 patients. American Journal of Infection Control, 37, 683–686. Lopez, V., Molassiotis, A., Chan, W., Ng, F., & Wong, E. (2004). An intervention study to evaluate nursing management of peripheral intravascular devices. Journal of Infusion Nursing, 27, 322–331. Machado, A., Pedreira, M., & Chaud, M. (2008). Adverse events related to the use of peripheral intravenous catheters in children according to dressing regimens. Rev Latino-am Enfermagem, 16, 362–367. Maki, K., & Ringer, M. (1991). Risk factors for infusion-related phlebitis with small peripheral venous catheters: A randomized control trial. Annals of Internal Medicine, 114, 845–854. McCullen, K., & Pieper, B. (2006). A retrospective chart review of risk factors for extravasation among neonates received peripheral intravascular fluids. Journal of Wound, Ostomy, and Continence Nursing, 33, 133–139. Moureau, N., & Iannucci, A. (2003). Catheter securement: Trends in performance and complications associated with the use of either traditional methods or an adhesive anchor device. Journal of Vascular Access Devices, 8, 29–33. O'Grady, N., Alexander, M., Burns, L., Dellinger, P., Garland, J., Heard, S., Lipsett, P., Masur, H., Mermel, L., Pearson, M., Raad, I., Randolph, A., Rupp, M., Saint, S., & HICPAC (2011). Guidelines for the prevention of intravascular catheter-related infections. American Journal of Infection Control, 39, S1–S34. Pearson, M. (1996). HICPAC guideline for prevention of intravascular device-related infections: Part 1 and part 2. American Journal of Infection Control, 24, 262–293. Pettit, J. (2003). Assessment of the infant with a peripheral intravenous device. Advances in Neonatal Care, 3, 230–240. Pondinas, H. (2008). Securing peripheral intravenous catheters in pediatrics: A comparative study of two securement techniques (Master's thesis). Available from ProQuest Dissertations and Theses database. (UMI No. 1459945). Powell, J., Tarnow, K., & Perucca, R. (2008). The relationship between peripheral intravenous catheter indwell time and the incidence of phlebitis. Journal of Infusion Nursing, 31, 39–45. Royer, T. (2003). Improving short peripheral IV outcomes: A clinical trial of two securement methods. The Journal of Association for Vascular Access, 8, 45–49. Runyan, D., Stern, J., Macri, I., Stango, C., Vacca, M., & Riddick, S. (2011). Peripheral IV securement device implementation to reduce phlebitis and associated infections. American Journal of Infection Control, 39, E193–E194.
6 Schears, G. (2006). Summary of product trials for 10,164 patients: Comparing an intravenous stabilizing device to tape. Journal of Infusion Nursing, 29, 225–231. Shah, P., Ng, E., & Sinha, A. (2009). Heparin for prolonged peripheral intravenous catheter use in neonates. Cochrane Database of Systematic Reviews, http: //dx.doi.org/10.1002/14651858.CD002774 Art. No: CD002774. Sheppard, K., LeDesma, M., Morris, N., & O’Connor, K. (1999). A prospective study of two intravenous catheter securement techniques in a skilled nursing facility. Journal of Intravenous Nursing, 33, 151–156. Smith, B. (2006). Peripheral intravenous catheter dwell times: A comparison of 3 securement methods for implementation of a 96-hour schedule change protocol. Journal of Infusion Nursing, 29, 14–17. Tofani, B., Rineair, S., Gosdin, C., Pilcher, P., McGee, S., Varadarajan, K., & Schoettker, P. (2012). Quality improvement project to reduce infiltration and extravasation events in a pediatric hospital. Journal of Pediatric Nursing, 27, 682–689. Tripathi, S., Kaushik, V., & Singh, V. (2008). Peripheral IVs: Factors affecting complications and patency-a randomized control trial. Journal of Infusion Nursing, 31, 182–188.
N. Laudenbach et al. Weber, M., & Sparks, J. (2005). Use of a catheter-securement device in pediatric patients with decreased skin integrity. Journal of Wound, Ostomy, and Continence Nursing, 32, 269–270. Webster, J., Osborne, S., Hall, J., Rickard, C., & New, K. (2013). Clinically indicated replacement versus routine placement of peripheral venous catheters. Cochrane Database of Systematic Reviews, http: //dx.doi.org/10.1002/14651858.CD007798 Art. No: CD007798. White, S. (2001). Peripheral intravascular therapy-related phlebitis rates in an adult population. Journal of Intravenous Nursing, 24, 19–24. Wood, D. (1997). A comparative study of two securement techniques for short peripheral intravenous catheters. Journal of Intravenous Nursing, 20, 280–285. Wood, D., & Bowe-Geddes, L. (1997). A comparative retrospective analysis of two securement techniques for peripherally inserted central catheters and midlines in the homecare setting. Journal of Vascular Access Devices, 2, 11–16. Yamamoto, A., Solomon, J., Soulen, M., Tang, J., Parkinson, K., Lin, R., & Shears, G. (2002). Sutureless securement device reduces complications of peripherally inserted central venous catheters. Journal of Vascular and Interventional Radiology, 13, 77–81.
Peripheral IV Stabilization and the Rate of Complications in Children: An Exploratory Study1,2 Nikki Laudenbach MSN,RN a , Carie A. Braun PhD b,⁎, Leigh Klaverkamp BSN,RN a , Sigrid Hedman-Dennis MS,CNS b a
St. Cloud Hospital, St. Cloud, MN Department of Nursing, College of St. Benedict/St. John's University, St. Joseph, MN
b
Received 28 October 2013; revised 4 February 2014; accepted 4 February 2014
Key words: Children; Intravenous; Stabilization; Complications
Peripheral intravascular catheter insertion is the most common invasive procedure performed on the hospitalized child with a significant potential for complications. This study compared complication rates between a standard aseptic taping technique and a commercially-available adhesive anchoring device in 80 hospitalized children ages 2–17 years. Eighteen (18) participants (22.5%) experienced a complication with occlusion being the most common (n = 8) followed by infiltration (n = 4), leaking (n = 3), and dislodgement (n = 2). There were no differences in complication rates or types between the two groups. This study provides evidence that a stabilization device may not be necessary in shortduration PIVs in children. © 2014 Elsevier Inc. All rights reserved.
THE INSERTION OF a peripheral intravascular (PIV) access device is one of the most common invasive procedures performed on hospitalized children. However, the placement of a PIV access device increases the risk for the development of phlebitis, infection, infiltration, and extravasation. Children are particularly vulnerable to these PIV-induced complications. In one surveillance report, neonates were impacted by these complications at nearly twice the rate of adults, particularly in critical care areas (O'Grady et al., 2011). In other studies, PIV complications were reported at rates as high as 28% in children (Garland et al., 1992; Pettit, 2003) compared to 8.5% in adults (Flippo & Lee, 2011) leading to prolonged hospitalization, increased medical costs, higher mortality, and greater morbidity in both groups (McCullen & Pieper, 2006; Pearson, 1996; White, 2001).
1 This research was supported by a faculty development and research grant from the College of St. Benedict/St. John's University. 2 The authors of this manuscript are not affiliated in any way with the intravenous stabilization product used in this study. ⁎ Corresponding author: Carie A. Braun, PhD. E-mail address: [email protected].
0882-5963/$ – see front matter © 2014 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.pedn.2014.02.002
The cause of PIV complications has most often been attributed to bacterial colonization and unintended catheter movement. Inadequate hand hygiene, lack of aseptic technique, and prolonged indwell time, maintained at 72 hours and beyond, has been consistently associated with increased incidence of phlebitis and infection (Powell, Tarnow, & Perucca, 2008; Tripathi, Kaushik, & Singh, 2008). In one study, over 50% of children experienced infiltration or phlebitis after 96 hours of PIV placement (Tripathi et al., 2008). In addition, small veins, the inability to verbalize or localize discomfort, underdeveloped immunity, and uncontrolled movement are developmental characteristics of young children contributing to the loss of PIV patency and the subsequent onset of complications (Cornely, Berthe, Pauls, & Waldschmidt, 2002; Doellman et al., 2009; Lee et al., 2009; Maki & Ringer, 1991; McCullen & Pieper, 2006). Since the 1990s, there has been growing interest in the use of commercially-available adhesive devices to stabilize PIV catheters in adults. In most studies, complication rates were reduced dramatically compared to stabilization using tape, gauze, or sutures (Moureau & Iannucci, 2003; Royer, 2003; Runyan et al., 2011; Schears, 2006; Sheppard, LeDesma,
2 Morris, & O’Connor, 1999; Wood, 1997; Wood & BoweGeddes, 1997; Yamamoto et al., 2002) with few exceptions (Bausone-Gazda, Lefaiver, & Walters, 2010). Additionally, Flippo and Lee (2011) evaluated the clinical effectiveness of the Sorbaview SHIELD, a sterile adhesive, with a particular interest in cost reduction. The authors reported a change in practice from StatLock to the new Sorbaview SHIELD and a direct cost savings of $120,000/year. Yet even with this change, unscheduled restarts reached 8.5% due to dislodgement, leaking, occlusion, or infiltration, well above the goal of b 5% recommended by the Infusion Nurses Society (2006). More recently, research on adhesive anchoring devices have been conducted in the pediatric population with mixed results. Pondinas (2008) determined no difference in the longevity of the PIV catheter compared to securement with a sterile transparent dressing, however, there was a statistically significant reduction in complications with the children in which the stabilization device was used. Heltz (2009) found complication rates were higher in PIVs for children where StatLock was used alone (43%) compared to a control group (35%) and those with a combination of House UltraDressing and StatLock (15%). Also, the StatLock Pediatric device was rated as difficult to use by almost half of the nurses, especially for “small” children and those less than 8 years of age (Heltz, 2009). In 2011, the Infusion Nurses Society recommended sufficient stabilization of PIV catheters, with preference given to manufactured adhesive anchoring devices (Infusion Nurses Society, 2011). In the same year, guidelines published in the American Journal of Infection Control also recommended sutureless securement devices to reduce the risk of infection with intravascular catheters (O'Grady et al., 2011). This standard was based on suggestive evidence for effectiveness comparing sutures to StatLock in PICC lines in adults (Yamamoto et al., 2002). The universality of this recommendation, however, has not been established in either adults or children, and the routine use of such devices has not yet permeated nursing practice. The purpose of this study was to explore PIV securement and stabilization and the resulting PIV complications by comparing a standard sterile transparent dressing and the StatLock securement device in children (StatLock® IV Select Pediatric Stabilization Device, Venetec International Inc./Bard Access Systems, Salt Lake City, Utah).
N. Laudenbach et al. the child was between 2–17 years of age, and the parent/ guardian consented to participation. Participants admitted to the pediatric unit with a PIV already in place were excluded from the study as well as those with a known adhesive allergy or those with a PIV insertion angle, such as the antecubital or scalp veins, that were not conducive to the use of the StatLock Pediatric stabilization device. Also, children under 2 years of age were excluded due to the challenges of securing the StatLock stabilization device to small surface areas of their extremities. Thirty-seven (37) participants were required in each of the taping method and StatLock stabilization device groups based on power = .80, 2-tailed test with alpha = .05 assuming a 19.005% predicted difference in complication rates between the two groups (Kraemer & Thiemann, 1987). This was a conservative estimate as similar studies reported complication rate reductions in excess of 30% (Royer, 2003). Training on human subject and study procedures commenced for nursing staff and research assistants using a training video, return demonstration, and an instructional poster placed centrally on the pediatric unit. Parents/ Guardians and patients were approached directly by the staff nurses in conjunction with the principal investigators or trained co-investigators to inquire about interest in study participation and to determine eligibility. Following the consent and assent process, children were placed into the intervention or control group by alternating eligible participants (the first eligible participant was placed in the control group; the second was in the intervention group, etc.). A study packet was placed on the nurses' station with instructions on the study protocol, consent and assent forms, and data collection sheets. Data were collected between July 2010 and August 2012. The study was approved by the facility's institutional review board. In the control group, each PIV was inserted and maintained in accordance with the pediatric unit policies and procedures utilizing a 3 M Tegaderm™ IV 1610, an arm
Method The study was conducted at a 489-bed midwestern regional medical center with a 20-bed pediatric unit. The sample location was selected due to accessibility of children in the desired age range and access to children who required PIV insertion. Participants were enrolled if the following conditions were met: a PIV catheter placement was needed,
Figure 1 and tape.
Method for securing with a sterile transparent dressing
Comparison on Peripheral IV Stabilization board, 1 inch 3 M tape, and 3 inch 3 M tape for securement. The final product is shown in Figure 1. For the intervention group, policies and procedures were also upheld with the addition of the StatLock stabilization device. The supplies utilized for stabilization with the StatLock came prepackaged and included an adhesive strip, the StatLock device, and transparent dressing. This is shown in Figure 2. Peripheral IVs were then observed for both the control and intervention groups until removal. Complications were defined as evidence of phlebitis (inflammation of a vein), extravasation (rupture of the vein after administration of a harsh IV solution), infiltration (inadvertent administration of a solution/medication into surrounding tissue) and/or other unexpected reasons for removal, such as occlusion, leaking, or dislodgement.
Results Data were entered into SPSS (19.0) and analyzed using descriptive and inferential statistics. Statistical significance was determined at p ≤ .05. Descriptive statistics were applied to categorical and continuous variables to obtain information about the overall sample and each group with regard to age, sex, PIV indwell time in hours, PIV fluid type and rate in mL/hr, PIV location, medications administered through the PIV, the reason for removal, and the type of complications, if any. Inferential statistics compared the differences in outcome for the two groups, via chi square or t test for independent groups, to determine statistical significance between each variable and the influence on peripheral IV complications.
3 The final convenience sample consisted of 80 children: 36 used StatLock and 44 were in the standard taping group. The smaller StatLock group was a result of significant missing data (n = 3) or parent acceptance to participate in the study only if the standard taping method was used (n = 5). There were no statistically significant differences between the two groups with regard to demographic variables. The mean age of participants was 7.94 years of age. There were 31 males and 47 females with an average PIV catheter indwell time of 37.98 hours. Among the entire sample, the most common placement site was the left hand (n = 39) followed by the right hand (n = 22) and then the left forearm (n = 5). Of the 69 participants on medications, most were on multiple IV medications (n = 25) followed by singular antibiotics (n = 22), opiate analgesics (n = 7) and antiemetics (n = 7). Seventy-three (73) of the participants had PIV fluids administered during the study with the most common solutions being D5 + ½ NS + KCL 20 mEq/L (n = 53) followed by normal saline (n = 5) at an average of 58.36 mL/hr. The most common reason for removal was completion of IV therapy (n = 53) followed by presence of a complication requiring restart (n = 16) and then by accidental removal by patient or complication not requiring a restart (n = 11). Among the sample, 18 out of 80 participants (22.5%) experienced some type of PIV complication with occlusion being the most common complication (n = 8) followed by infiltration (n = 4), leaking (n = 3), and dislodgement (n = 2). The two groups were almost identical in the type of complication experienced by each. Chi square statistics were applied to determine any statistically significant difference between the two groups. There were no differences in complication rates between the taping and StatLock groups (p = .957). These results are summarized in Table 1. Additionally, chi square statistics were applied to categorical variables to determine any statistically significant difference between those who experienced a PIV complication and those who did not, separate of stabilization procedure. There were no differences in complication rates for females compared to males (p = .118). Similarly, when adding stabilization as a variable, there were no differences among males and females in complication rates by taping Table 1 Complication rates comparing taping and StatLock Groups. StatLock stabilization (n = 36)
Figure 2 device.
Method for securing with a StatLock ® stabilization
Taping stabilization (n = 44)
No complications 28 (77.8%) 34 (77.3%) Complications-total 8 (22.7%) 10 (22.5%) Complications-by type Infiltration = 2 Infiltration = 2 Phlebitis = 1 Phlebitis = 0 Occlusion = 3 Occlusion = 5 Dislodgement = 1 Dislodgement = 1 Leaking = 1 Leaking = 2
4
N. Laudenbach et al. Table 2
Administration of medications and complication rates between the taping and StatLock Groups. StatLock
0 meds 1 med 2 + meds Total
Total
+ Complications, n (%)
− Complications, n (%)
6 (23.1%) 4 (50.0%) 3 (37.5%)
1 (12.5%) 14 (53.8%) 6 (23.1%)
Taping
7 (20.6%) 18 (52.9%) 9 (26.5%) p = .660
Total
+ Complications, n (%)
− Complications, n (%)
1 (8.8%) 4 (44.4%) 4 (44.4%)
3 (11.1%) 19 (55.9%) 12 (35.3%)
4 (9.3%) 23 (53.5%) 16 (37.2%) p = .829
*Statistical significance = p ≤ .05.
method (p = .114) versus StatLock stabilization (p = .562). The only categorical variable that appeared to be trending toward statistical significance on first glance was the number of medications administered and complication rates among the two groups (Table 2). More participants in the StatLock group appeared to have a greater rate of complications when no medications were administered as well as when one or multiple medications were administered through the PIV site, although this was not confirmed statistically. The overall statistical significance between the StatLock and taping groups was p = .683. Independent samples t tests were then applied with respect to the presence or absence of complications to compare differences in age (p = .891), PIV catheter indwell time (p = .144), and PIV fluid rate (p = .717). The longer indwell times and rate of complications in the StatLock group is visually larger and longer in duration but did not reach statistical significance. Due to a smaller sample size comparing the stabilization devices and complications, a Mann–Whitney U test was conducted to verify statistical power. The mean rank difference was also not statistically significant between the StatLock and taping groups (U = 30.00, p = .374, r = − .889) for those with and without complications (Table 3). In summary, there were virtually no differences between the standard taping method and the StatLock group with regard to PIV complications.
Discussion This study contributes to the evidence regarding stabilization of PIVs and the resulting rate of complications in children. The hypothesis that children will have a significant fewer PIV complications with the StatLock device was not Table 3
supported in this sample. In addition, no other study variables impacted the rate of complications and neither securement procedure was effective in reducing the complication rate below 5% (Infusion Nurses Society, 2006). The interest in reducing complication rates through improved PIV stabilization continues to be an important but challenging endeavor. Despite research reports on successes gained through stabilization of PIVs, complication rates remain extraordinarily high (Callaghan, Copnell, & Johnston, 2002; Machado, Pedreira, & Chaud, 2008; Royer, 2003; Schears, 2006; Sheppard et al., 1999; Wood & Bowe-Geddes, 1997) demonstrated by post-intervention complication rates ranging from 36–52% in control groups and 14%–36% in intervention groups. Several explanations for the results have been considered. Stabilization with a transparent dressing and tape and the commercially-available anchoring adhesive device may be equally effective in short-duration PIVs. In this study, PIV indwell times averaged just over 1 1/2 days. The shortened time with the PIV in place could impact the value of stabilization products. For PIVs with a longer indwell time, securement may play a larger role. Smith (2006) noted that the 96-hour indwell survival rate for PIVs was 52% for StatLock compared to 8% for non-sterile tape securement. This is certainly a consideration when PIVs must be maintained for greater than 96 hours. Other reports have also indicated greater success when securing tubing that can more easily become unstable, such as PICCs, urinary catheters, chest tubes, or peritoneal dialysis catheters (Weber & Sparks, 2005; Wood & Bowe-Geddes, 1997). Conclusive evidence on best practices for PIV insertion and maintenance appears limited to frequent assessment, strictly aseptic insertion technique, and the use of an arm board splint, in children where uncontrolled movement is expected (Bierman, 2003; Center for Disease Control and
Comparing complication rates based on age and indwell time. p Value ⁎
StatLock
Age (in years) Indwell time (in hours)
+ Complications (n = 8) M (SD)
− Complications (n = 28) M (SD)
8.88 (6.96) 61.33 (64.08)
9.61 (5.15) 31.23 (22.04)
⁎ Statistical significance = p ≤ .05.
.744 .230
p Value ⁎
Taping + Complications (n = 10) M (SD)
− Complications (n = 34) M (SD)
6.90 (5.63) 54.65 (77.35)
6.65 (5.39) 32.92 (22.67)
.897 .402
Comparison on Peripheral IV Stabilization Prevention, 2002; Kulkarni, 2001). Cochrane collaborative groups have found no evidence for changing catheters every 72–96 hours (Webster et al., 2013), insufficient support for heparin use in neonates to prolong catheter patency (Shah, Ng, & Sinha, 2009), and insufficient evidence to support intermittent versus continuous flushing of catheters (Flint, McIntosh, & Davies, 2009). In a few studies, nursing staff engagement and education do appear to have an impact on PIV success (Boyd et al., 2011; Hetzler et al., 2011; Lopez et al., 2004; Tofani et al., 2012), but the persistence of behavior change through educational interventions is unknown. The study is limited by a convenience sample at one facility and cannot be generalized to the population. Also, the StatLock was not appropriate for children under 2 years of age and in certain PIV locations with a small surface area. The decision not to explore cost comparisons and potential cost savings was also a limitation of this study. Not surprisingly, few studies on PIV catheter securement are randomized or otherwise fit the criteria for rigorous clinical trials (Alekseyev et al., 2012). Yet researchers and practitioners must continue to search for the best evidence to reduce PIV complications across all populations, particularly children. Future research should therefore consider other causative variables contributing to short-duration PIV complications and potential cost controls in randomized clinical trials in an effort to eliminate PIV complications entirely.
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