BACKGROUND AND OBJECTIVES: Pressure ulcers are commonly acquired in pediatric institutions, and they are a key indicator of the standard and effectiveness of care. We recognized a high rate of tracheostomy-related pressure ulcers (TRPUs) in our ventilator unit and instituted a quality improvement program to develop and test potential interventions for TRPU prevention, condensed them into a clinical bundle, and then implemented the bundle into our standard practice.
METHODS: The intervention model used a rapid-cycle, Plan-Do-Study-Act (PDSA), framework for improvement research. All tracheostomy-dependent patients admitted to our 18-bed ventilator unit from July 2008 through December 2010 were included. TRPU stage and description, number of days each TRPU persisted, and bundle compliance were recorded in real time. All TRPUs were staged by a wound-care expert within 24 hours. The interventions incorporated into the TRPU-prevention bundle included frequent skin and device assessments, moisture-reducing device interface, and pressure-free device interface.
RESULTS: There was a significant decrease in the rate of patients who developed a TRPU from 8.1% during the preintervention period, to 2.6% during bundle development, to 0.3% after bundle implementation. There was a marked difference between standard and extended tracheostomy tubes in TRPU occurrence (3.4% vs 0%, P = .007) and days affected by a TRPU (5.2% vs 0.1%, P < .0001).
CONCLUSIONS: Education and ongoing assessment of skin integrity and the use of devices that minimize pressure at the tracheostomy–skin interface effectively reduce TRPU even among a population of children at high risk. These interventions can be integrated into daily workflow and result in sustained effect.
- PDSA —
- TRPU —
- tracheostomy-related pressure ulcers
Hospital-acquired pressure ulcers are common in pediatric institutions. Reported prevalence rates are 4% to 27.7%, and incidence rates are 0.29% to 32.8%.1–5 A 2003 national survey documented an average 4% prevalence rate of stage 3 to 4 pressure ulcers among pediatric hospitals.1 Data for 2010 from the National Database of Nursing Quality Indicators report a mean prevalence of 2.29% for hospital-acquired pressure ulcers in “step down” units at academic pediatric hospitals. Pressure ulcers are associated with increased pain, infection, and prolonged hospitalization, and they may result in permanent scarring.6–8 Pressure ulcers are considered a high-cost, high-volume, preventable condition. They have received increasing attention, and pediatric hospital days associated with a facility-acquired pressure ulcer will be disqualified from Medicare and Medicaid reimbursement effective July 1, 2012.9
After recognition that our hospital’s rate of all facility-acquired pressure ulcers was greater than national averages, a pressure ulcer collaborative, including members from all high-risk units, was convened. This collaborative is a multidisciplinary team focused on the prevalence and occurrence monitoring, education, assessment of risk and skin integrity, and the development of skin care teams on high-risk units. Initial interventions from this collaborative resulted in a decreased prevalence of pressure ulcers (from all sources) from 9.2% to 2.4% in our institution. The hospital collaborative identified that ∼75% of remaining pressure ulcers in our pediatric population were being caused by medical devices; many of these were due to respiratory devices such as tracheostomy tubes and positive-pressure masks.
Tracheostomy tubes cause pressure ulcers by creating a constant pressure interface over the skin of the neck with additional disruption of skin integrity due to wetness from sweat and respiratory secretions. Furthermore, tracheostomy tubes are often used in children with limited mobility and neurologic responsiveness, which further increases the risk for ulcer development. There are no published prevalence rates of pressure ulcers specifically caused by tracheostomy tubes, but one study reported that 27% of complications before the first tube change were related to skin breakdown.10 The baseline occurrence rate of tracheostomy-related pressure ulcers (TRPUs), in our hospital unit with the greatest utilization of tracheostomies, was determined to be 8.1% for all stages. We hypothesized that quality improvement methodology would both (1) identify those interventions that were most effective at preventing TRPUs and (2) result in a reliable implementation that would sustainably decrease the occurrence of TRPUs in our unit.
This project was granted exemption from the Institutional Review Board of Cincinnati Children’s Hospital Medical Center. All tracheostomy-dependent patients admitted to the Transitional Care Center at our hospital from July 2008 through December 2010 were included.
Our hospital is a 490-bed academic quaternary-care, free-standing children’s hospital. The Transitional Care Center is an 18-bed multidisciplinary unit whose primary mission is the transition of children requiring invasive and noninvasive mechanical ventilation to home. This unit also serves as a stepdown ICU for ventilation-dependent children admitted for acute illness, surgical procedures, or diagnostic testing. This unit handles >400 admissions per year, the majority of which are tracheostomy dependent, ventilator dependent, and young. There was a gradual increase in tracheostomy patient days over the study period: 3388 in 2008, 4097 in 2009, and 4441 in 2010. The clinical and demographic characteristics of the study population are presented in Table 1.
All tracheostomy-dependent patients from July 2008 through December 2010 were included. Demographic information, use of mechanical ventilation, and underlying cause for mechanical ventilation were reviewed retrospectively. Tracheostomy type, TRPU stage and description, number of days each TRPU persisted, and bundle compliance were recorded in real time. In most cases, the TRPUs were photographed to document the stage, location, and relationships between the respiratory equipment and the patient.
A TRPU occurrence was defined as a new pressure ulcer that developed after the patient was admitted or transferred to our unit, if the ulcer site was in direct contact with the tracheostomy tube, tracheostomy ties, or the connection to a ventilator circuit. To improve our ability to detect an improvement, any stage TRPU was considered an occurrence, even though national patient safety guidelines focus only on stage 3 and 4 pressure ulcers. All TRPUs were identified by a bedside nurse or during monthly unitwide surveys. All TRPUs were reported to and staged by a wound-care expert (AM.N.), based on National Pressure Ulcer Advisory Panel staging system, within 1 day of initial diagnosis.11 The diagnosis and staging were made independent of the clinical service. TRPU occurrence rates were expressed as the number of new TRPUs per month divided by the number of tracheostomy patients in the unit that month. TRPU bed days were expressed as the number of days associated with a TRPU per month divided by the total number of unit bed days with a tracheostomy tube.
The intervention model used a rapid-cycle, Plan-Do-Study-Act (PDSA), framework for improvement research.12 PDSA cycles are designed to establish relationships between process changes and outcomes by trialing and adapting small-scale interventions over time. This process was used both to determine the interventions most beneficial to prevent TRPU and to effectively implement a TRPU-prevention bundle. PDSA cycles were planned and executed by a multidisciplinary team including the medical director of the unit, bedside nurse and respiratory therapist, nurse educator, and the unit’s skin care champion. Based on knowledge gained from the literature, as well as results previously obtained from our institution’s pressure ulcer collaborative (preliminary work to reduce pressure ulcers of all types), key drivers thought to prevent TRPU development were identified to guide our interventions. These included (1) pressure ulcer risk and skin assessment, (2) moisture-free device interface, and (3) pressure-free device interface. PDSA cycles testing interventions in each of these drivers were undertaken in series. Once effective interventions were identified, they were incorporated into a TRPU-prevention “bundle” and implemented with the use of quality improvement methodology. All patients were monitored for any changes in their oxygenation or ventilation. In the event of a decision to deviate from a component of the bundle (because of an adverse event, cost, or preference) the reason was recorded. All other quality improvement initiatives on the unit continued and their success was monitored.
On-line training modules on pressure ulcer risk assessment (all types), skin assessment, and identification were completed by all nurses on the unit. Specific education related to prevention of TRPU was given to staff as part of ongoing education and in printed form. Details of the TRPU-prevention bundle was well as data demonstrating time since he last TRPU were displayed in the staff break room. Nursing and respiratory therapists were given a brochure to share with parents describing the risks and mechanism of TRPU development and explaining why we were implementing this bundle. Pressure ulcer risk assessment was performed and documented via the Braden Q score of pressure ulcer risk.13,14 In addition, full body skin assessments and device assessments were performed. Mepilex lite (Mölnlycke Health Care, Norcross, GA) was the hydrophilic barrier used under the tracheostomy tube flanges and around the stoma, cut to size from the supplied sheets. As the strength of the relationship between tracheostomy tube type and TRPU was increasingly recognized, consultation with a tracheostomy tube manufacturer was undertaken to develop a tube that meets the needs of ventilator-dependent children and minimizes the pressure interface at each of the 3 locations where TRPUs develop. Arcadia Extend Connect Perfect Fit (Arcadia Medical, Crown Point, IN) tracheostomy tubes were primarily used, although Bivona FlexTend (Smiths Medical, London, UK) tracheostomy tubes were used as well. Both of these brands of tracheostomy tubes feature a flexible extension separating the flanges and the 15-mm adapter and are available in all pediatric and neonatal sizes (cuffed and uncuffed). Either brand of tube was designated “extended” tracheostomy tubes for the purpose of this study based on similar mechanism of removing bulk from the crowded anatomic location of a small child’s neck (Fig 1). Tracheostomy tubes were further modified to have thin flanges at a 30% angle which conforms well to the neck contours of an infant or young child (Arcadia, Perfect Fit). Extended tracheostomy tubes were incorporated into our hospital storage and distribution system such that there are no delays in ability to change a patient’s tracheostomy to such a tube if indicated. Once the bundle was developed, multiple actions were taken to impact sustainable implementation. These actions included incorporation of assessment into nursing workflow via the electronic medical record, real-time reporting of each TRPU occurrence, and a strategy to change tracheostomy tubes in the unit based on patient anatomy and to place such tubes at the time of tracheostomy (via collaboration with Otolaryngology).
A multiple time series analysis was performed to determine whether the occurrence rate of TRPU decreased over the study period. Run charts were created to document monthly TRPU occurrence rate and percent of tracheostomy patient days affected by a TRPU each month. Run charts display and analyze variation in time-series data. They can statistically identify changes in variation that are attributable to a change in a system.15 A run chart was used to graph the monthly TRPU occurrence rate over time and identify when a change in TRPU occurrence was emerged. Associations between TRPU development and age, gender, and the clinical indications for mechanical ventilation listed in Table 1 were evaluated by multiple logistic regression. The rate of TRPU occurrence between those with a standard and extended-style tracheostomy tubes was evaluated by Fisher's exact test.
From July 2008 to December 2010, there were 834 tracheostomy patients and 10 132 tracheostomy patient days evaluated. Population characteristics are shown in Table 1. During the 6 months of data collection before intervention there were 11 TRPUs in 136 patients for an occurrence rate of 8.1 per 100. This resulted in 212 bed days associated with a TRPU (12.5% of all tracheostomy days).
There were 22 TRPUs over the study period (Table 2). Eight TRPUs were stage 3 or 4 in severity (36%). Most occurred below the tracheostomy stoma (73%) and in patients who were <2 years old (64%) and ventilator dependent (82%). All of the pressure ulcers occurred in children with a mature stoma (a mature stoma is a requirement for the unit). No associations were found between any of the individual clinical or demographic characteristics listed in Table 1 (including age and ventilator status) and likelihood of developing a TRPU.
Based on the results of PDSA cycles, interventions identified for incorporation into the TRPU-prevention bundle for each key driver included the following: skin assessment, Braden Q performed and documented every 24 hours, full body skin assessments performed daily, and tracheostomy device assessments every 8-hour shift; moisture-free device interface, hydrophilic polyurethane foam under tracheostomy tubes to wick moisture from the stoma away from the skin surface; pressure-free device interface, extended-style tracheostomy tubes in children with anatomy in which the neck was not clearly exposed in the neutral position or those with behaviors than repeatedly drove the tube down into the sternum (Fig 1).
It was clear from PDSA cycles trialing extended tracheostomy tubes that there was much less visible pressure at the tracheostomy–skin interface from this style of tube. This was further borne out over the entire study period in which 22 of 638 (3.4%) patients with standard tracheostomy tubes developed a new TRPU in comparison with 0 of 174 of patients with extended tubes (P = .007). There was also a significant difference in days affected by a TRPU between the 2 groups (5.2% vs 0.1%, P < .0001). One patient was transferred from an outside hospital during the first study month in an extended tracheostomy tube with an existing TRPU that persisted for 5 days. The intervention of extended-style tracheostomy was prioritized, and weekly audits were initially performed to ensure that appropriate patients had these tubes as soon as they were admitted or transferred to our unit. Once a week, 2 authors (N.T. and R.P.B.) surveyed all the current patients on the unit to determine which components of the bundle had been completed or were in place that day. Rates for each component and the full bundle were tracked. Within 4 months the culture of the unit staff changed such that compliance with the bundle is consistently 100%, and audits are now done monthly. This type of integration of positive change into routine workflow is a hallmark of sustainable improvement.
The TRPU-prevention bundle was well accepted. There were no adverse events associated with the use of extended tracheostomy tubes. There were no instances of change in ventilation or oxygenation, no increased tube plugging, or any increased difficulty reported with tracheostomy tube changes. The cost per unit varies, but on average the extended-style tracheostomy tubes cost approximately twice as much as standard tubes. There were no instances of inability to continue use of these tubes, but in some circumstances patients received only 1 tube per month (instead of 2, which is our standard) and were required to clean and replace tubes at least once. This is a practice that is accepted, and there are manufacturer’s recommendations for doing so. One parent requested to change back to a standard tracheostomy tube for cosmetic reasons. The polyurethane barrier was less well accepted. Three patients changed back to a gauze barrier because contact dermatitis, and 12 additional patients changed because the cost was not covered by insurance. This represents a small percentage of the total population evaluated (2%).
Overall, during the study period, there was a significant decrease in the rate of tracheostomy patients who developed a TRPU from 8.1% during the baseline period to 0.3% over the final 6 months of the study period (Fig 2). The percentage of tracheostomy patient days affected by a TRPU also decreased from 12.5% to 0.2% during the same time interval.
In our population of mostly young, chronically ventilated infants and children, tracheostomy-related pressure ulcers were common, but they proved to be largely preventable by a culture of prioritizing skin health and the use of anatomically appropriate devices. During the 6 months before initiation of this study, there were 11 ulcers, 4 of which were staged at 3 or 4. Based on the newly accepted changes to Medicare and Medicaid reimbursement, the entire direct care costs for hospital days associated with these pressure ulcers would have been disqualified.
Education of nursing staff in skin assessment and risks for pressure ulcer development, with integration of these assessments into daily documentation workflow, has improved our ability to anticipate and mitigate risks to skin integrity. In addition to decreasing the occurrence of TRPUs, there was a trend toward shortening their duration. During the first 6 months of the study, each TRPU lasted an average of 19 days, whereas the TRPU that developed during and after implementation lasted only 7 days.
Pressure ulcers are a key clinical indicator of the standard and effectiveness of care, yet there have been no guidelines as to prevention of pressure ulcers from tracheostomy tubes. We were able to use the risk factors for pressure ulcer development, within a quality improvement framework, to guide the development and testing of potential interventions for TRPU prevention.16–19 This framework allowed us to evaluate the effectiveness of different interventions, condense them into a clinical bundle, and then implement this bundle into the clinical practice of the unit. The benefits of this approach to TRPU prevention became evident during development of the clinical bundle, and the improvement has been sustained. The biggest driver of improvement was related to the use of tracheostomy tubes that exert a minimum of focal pressure, although the degree of improvement may not have been as great outside of a context of heightened attention to skin health. That said, the use of an extended tracheostomy tube in appropriate patients would be expected to be a highly reliable intervention, because, once placed, the beneficial impact would be continuous and would not rely on caregiver diligence or memory. We did not begin to see a significant improvement in our TRPU rates until these devices were used with some frequency. For this reason, this style of tracheostomy tube is now placed at the time of surgery in all anatomically appropriate children in our institution as an anticipatory measure. This has decreased the rate of TRPUs that transfer to our unit from the pediatric ICU that had previously developed during the short period of stoma maturation immediately after tracheotomy.
This study is limited by its single-hospital unit design and because it was not a randomized controlled trial. However, this unit has the highest tracheostomy utilization of any other unit in the institution. Several patients had previous TRPUs with standard tracheostomy tubes that did not recur after a change to an extended-style tube. Two patients had prolonged TRPUs that did not resolve until an extended tube was placed. These factors increase our confidence in our results, in particular, the effectiveness of extended tracheostomy tubes.
Education and ongoing assessment of skin integrity and the use of devices that minimize pressure effectively reduces TRPUs even among a population of children at high risk for pressure ulcer development. These interventions can be integrated into daily workflow, resulting in long-term sustainment in effectiveness.
- Accepted October 31, 2011.
- Address correspondence to R. Paul Boesch, DO, MS, Division of Pulmonary Medicine, Cincinnati Children’s Hospital Medical Center, ML 2021, 3333 Burnet Ave, Cincinnati, OH 45229-3039. E-mail:
FINANCIAL DISCLOSURE: The authors have indicated they have no financial relationships relevant to this article to disclose.
FUNDING: No external funding.
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- Copyright © 2012 by the American Academy of Pediatrics