Reducing Hospital-acquired Pressure Injuries Among Pediatric Patients Receiving ECMO: A Retrospective Study Examining Quality Improvement Outcomes

Hospital-acquired pressure injury (HAPI) is defined as localized damage to the skin and underlying soft tissue, usually over a bony prominence or related to a medical or other device. The pressure injury staging system is the criterion standard for classification of these injuries. The wound is numerically classified as stage 1, 2, 3, 4, or unstageable, based on the deepest tissue type exposed.^1-3 Hospital-acquired pressure injury is considered a preventable condition and a nursing-related quality indicator; thus, the incidence of HAPIs is tracked by hospitals and other safety organizations.^4,5

The reported prevalence of pediatric pressure injury ranges from 0.5% to 35%, with pediatric intensive care units (ICUs) having higher prevalence estimates, ranging from 7% to 44%.^6-16 The development of a HAPI is associated with increased length of stay, morbidity, and economic burden. In a study from 2009 to 2011 using the Nationwide Inpatient Sample database from the Healthcare Cost and Utilization Project, pressure injuries occurring in patients 1 to 4 years of age were found to be associated with an average length of stay of 14 days longer and average excess cost of almost $90,000 when compared with patients in this age category who did not acquire a pressure injury.¹⁷ Studies evaluating the application of prevention care bundles for pediatric ICU patients have found such application to reduce the incidence of HAPI development successfully.^15,18,19 However, there is less robust evaluation of the successful reduction in development of HAPI in pediatric patients requiring extracorporeal membrane oxygenation (ECMO).²⁰

The goal of this retrospective study was to evaluate the rate of HAPI occurrence in ECMO patients before and after implementation of a quality improvement initiative aimed at decreasing HAPI rates among such patients. Our aim was to determine if a change had occurred as a result of the quality improvement initiative implemented between August and December 2018 that consisted of HAPI prevention interventions and provider education for those who care for patients undergoing ECMO. The authors hypothesized that the number of ECMO patients who developed a HAPI decreased after implementation of the quality improvement preventive interventions and provider education.

Surveillance methods. Starting in 2012, a hospital policy with a HAPI prevention bundle including the 5 elements of skin assessment, device rotation, patient positioning, appropriate bed surface, and moisture management was implemented¹⁹ (Table 1, Part 1 and Part 2). The specific goals were to identify patients at risk of developing a HAPI and to provide guidelines for appropriate interventions to prevent HAPI formation. An interdisciplinary team was assembled to assess and provide the best interventions for preventing pressure injuries. This interdisciplinary team consisted of a nurse practitioner as Director of Wound Care, a plastic surgeon, a physical and occupational therapist, a dietician, 5 nurses who were certified in wound care, and 2 analysts. All pressure injuries were evaluated and staged by 2 certified wound care nurses. All of these in-place surveillance methods were maintained after the quality improvement education and new interventions were introduced in 2018.

Quality improvement education and interventions. In August 2018, a quality improvement initiative began and was continued until December 2018 to reach all ICU providers, including but not limited to nurses, nurse practitioners, physician assistants, and physicians. The initiative targeted HAPI prevention by providing both neonatal and pediatric ICU providers HAPI prevention education, fluidized positioner (Z-Flo Fluidized Positioner; Mölnlycke Health Care) provider education, and the addition of 2 wound care interventions for ECMO patients. The education consisted of pressure injury prevention education and targeted education at extracorporeal life support continuing education days in August, October, and December 2018 with both in-person sessions and virtual sessions. In addition to the education, a “dot phrase” (a feature of electronic medical record [EMR] systems in which data or text can be inserted into a note by pulling data from the patient’s chart) was added to all ECMO patients’ daily notes in the EMR with a specific place to address the risk of HAPIs by noting the following: head position, presence or absence of a soft 5-layer silicone foam dressing (Mepilex; Mölnlycke Health Care), presence or absence of a static seat cushion (EHOB, Inc.), presence or absence of a shoulder roll, cannula insertion site, risk of pressure injury formation, whether or not wound surveillance was occurring, and whether or not a wound consult had taken place. Use of the dot phrase feature can streamline the evaluation of factors such as these.

The 2 additional wound care interventions were as follows. The first intervention involved placing a soft, 5-layer silicone foam dressing from the occiput extending to the sacrum when the patient was stable either before or after ECMO cannulation on every patient, with the aim of preventing the development of HAPI. In the second intervention, mirrors were used to examine the back of patients during any repositioning, movement, or manipulation with the goal of identifying HAPI formation early and ensuring adequate visualization of all dependent body parts utilizing an appropriate amount of mobilization to maintain the safety of the ECMO circuit.

Study design. This retrospective cohort study included all patients younger than 18 years of age who underwent ECMO cannulation at a tertiary children’s hospital from January 2012 through March 2020. The retrospective analysis was begun in 2012, when HAPI evaluations were standardized at the authors’ institution, as detailed above. Patients were included if they were younger than 18 years of age and had undergone ECMO cannulation.

Demographic information, ECMO indication, date of ECMO cannulation and mode, date of ECMO decannulation, total ECMO run time, presence or absence of a HAPI, date of HAPI identification, HAPI location, and mortality were collected via EMR review and via the data collected by the institution for the Extracorporeal Life Support Organization. Total run time was the duration of ECMO use from initiation of ECMO until decannulation and was reported in days. Time to HAPI identification was calculated using the date of cannulation and the date of HAPI identification and was reported in days.

Patients were categorized by year of ECMO cannulation and by the presence or absence of a HAPI to determine whether there was a change in HAPI incidence from before implementation of quality improvement and education (ie, prior to August 2018) to after implementation of these efforts (ie, after December 2018). The primary outcome was the development of a stage 3, 4, or unstageable HAPI while the patient was undergoing ECMO. Stage 1 and 2 HAPIs were not included because they are not reported to the state and because our team has found that stage 1 and 2 HAPIs typically do not evolve to stage 3, 4, or unstageable; as with adults, pediatric patients develop stage 3, 4, or unstageable HAPIs from deep tissue injuries.²¹ Institutional review board approval (1582549-2) was obtained prior to the retrospective EMR review.

Statistical analysis. Data were compared using the chi-square test and Fisher exact test for categorical data and the Mann-Whitney U (Wilcoxon) statistic for continuous data. Values were considered significant at P < .05. Analysis was performed using Prism, version 8 for MacOS (GraphPad).

During the study period, 120 patients younger than 18 years of age were placed on ECMO. For the overall cohort of ECMO patients, the median age was 1.5 months (interquartile range [IQR], 0.1–21.1 months) and 65.8% (n = 79) were male. Of the 120 patients, 52.5% (n = 63) were cannulated for a cardiac indication and 47.5% (n = 57) were cannulated for a respiratory indication. The majority of patients were placed on venoarterial ECMO (n = 86, 71.7%) and with an overall median total run time of 4.9 days (IQR, 2.5–7.6 days). The overall mortality rate was 34.2% (n = 41) (Table 2).

Of all ECMO patients (n = 120), 5 (4.2%) developed a HAPI, all of which occurred prior to provider education and new wound care interventions instituted between August 2018 and December 2018. No ECMO patients treated at the authors’ institution after December 2018 developed a HAPI. The median age of patients who developed a HAPI was 1 month (IQR, 0.3–6.8 months), and the majority were male (n = 4 [80.0%]). All ECMO patients who developed a HAPI were cannulated in their right neck, with 60% (n = 3) of these patients on venoarterial ECMO and the other 40% (n = 2) initiated on venovenous ECMO and later converted to venoarterial ECMO. Four (4) of these patients (80.0%) required ECMO for a respiratory indication and 1 (20.0%) required it for a cardiac indication; specifically, these patients required ECMO to address pulmonary hypertension (n = 3), pneumonia resulting in respiratory failure (n = 1), and meconium aspiration resulting in cardiac arrest (n = 1). The median total run time was 8.5 days (IQR, 6.3–28.6 days). The median time to identification of a HAPI was 9.5 days (IQR, 4.8–32.3 days). All patients developed HAPI in the occipital region, and 1 had an additional HAPI on the back secondary to immobility (Figure 1). In all 5 patients the HAPI was unstageable owing to the presence of an eschar. The mortality rate for these 5 patients was 20.0% (n = 1) (Table 3).

There were no significant differences in age, sex, ECMO indication, or ECMO mode used between patients who developed a HAPI and those who did not. Patients who developed a HAPI did have a significantly longer total run time than patients who did not develop a HAPI (8.5 days vs 4.8 days; P = .02). There was no significant difference in mortality (20.0% vs 34.8%; P = .66).

The rate of HAPI formation in neonatal and pediatric ECMO patients per year was as follows: 7.7% in 2012, 0% in 2013, 0% in 2014, 0% in 2015, 4.6% in 2016, 0% in 2017, 20% in 2018, 0% in 2019, and 0% through March 2020. The rate was highest in the beginning of 2018, which was one of the driving factors for the quality improvement interventions. Since the implementation of provider education and the 2 wound care prevention interventions, the HAPI rate has been 0%, a decrease from 4.8% of ECMO patients prior to implementation (P > .99).

Overall, the development of a HAPI in pediatric patients on ECMO was 4.2% at the authors’ institution from January 2012 through March 2020. After the implementation of ICU provider education and additional wound care interventions, however, the rate of HAPI development was 0%.

Critically ill infants and children are at high risk for HAPI in pediatric critical care units. In a correlational analysis of data from a large dataset, a study evaluating approximately 40 000 pediatric patients from more than 270 hospitals participating in the National Database of Nursing Quality Indicators aiming to identify risk factors for HAPI, the odds of HAPI development were found to be approximately three times higher in patients in pediatric critical care units.²² A multicenter retrospective study consisting of 5346 children admitted to 9 participating ICUs found that there were specific risk factors for the development of a HAPI while in the ICU, one of which was requiring ECMO.¹⁵ Patients requiring ECMO were 2.5 times more likely than other pediatric ICU patients to develop a HAPI. Overall, ECMO patients often require extended periods of immobility, which is an independent risk factor for the development of HAPI. Of the ECMO patients who developed HAPI in our study, 100% of the injuries were secondary to immobility.

Concerning development of HAPI in patients on ECMO more specifically, a single-center study of 43 patients on ECMO found that patients who developed HAPI were older (133 vs 31 months; P = .001), remained on ECMO longer (487.5 hours vs 113.5 hours; P = .007), and were more likely to have femoral cannulation (36.4% vs 6.3%; P = .029).²³ The authors’ data were similar to these findings in that the present study showed a statistically significant difference in total run time between patients who developed a HAPI and those who did not (8.5 days vs 4.8 days; P = .02); in fact, in the present study, run time was almost double for patients who developed a HAPI. Interestingly, in the present study, the median number of days to the identification of a HAPI was 9.5, which was slightly longer than the median total run time; this suggests identification of HAPI may have occurred after decannulation. While the authors cannot comment on whether the HAPI developed while the patient was still cannulated but was not identified or whether it both developed and was identified after decannulation, they can speculate that prior to the use of mirrors for the evaluation of patients’ backs and occipital regions as well as the use of soft, 5-layer silicone foam dressings, in these patients these anatomic areas may not have been evaluated as frequently or thoroughly because the patients were relatively immobile throughout their time with ECMO cannulation. Therefore, it is possible that HAPI development was occurring during this time but was identified only after decannulation when the patient was mobilized more. This highlights the necessity of continuing to improve the identification of risk factors for HAPI development and the ability of pediatric or neonatal patients to be repositioned or have pressure redistributed if these patients are immobile secondary to the delicate ECMO cannulation. Importantly, since the addition of the correct use of fluidized positioners as a means of pressure redistribution at intervals, the addition of provider education, the use of mirrors for the evaluation of patients’ backs, and the use of soft, 5-layer silicone foam dressings to aid in pressure redistribution no patients have developed a HAPI at the authors’ institution.

Some of the mainstays of HAPI prevention are frequent repositioning and pressure offloading,^24,25 which can be difficult with ECMO patients because they have critical cannulas in place. Studies in adults have shown, however, that efforts to mobilize ECMO patients early have been successful in improving outcomes.^26,27 In pediatric patients, the utilization of early mobilization efforts has been less explored. A single-center quality improvement study from 2018 in a cardiac critical care unit implemented a HAPI protocol in which specific products, such as foam or hydrocolloid dressings and gel pillows, were used to redistribute pressure and protect bony prominences and patients were to be repositioned every 2 hours.²⁸ The quality improvement initiative reduced the rate of HAPI formation in the cardiac critical care unit from 2.7% pre-implementation to 1.4% post-implementation. Another single-center quality improvement study from 2020 with a sample of 110 patients reported a 16.7% decrease in HAPI rate after implementation of a critical care HAPI prevention bundle.¹⁸ Concerning ECMO patients specifically, one single-center quality improvement study implemented a prevention bundle in 2013 to decrease the overall incidence of pediatric HAPIs.²⁹ The authors of that study found that HAPI occurrence was reduced in ECMO patients by 30% from 2014 to 2016 and by 40% in 2017. Similarly, data from the present study showed a decreased rate of HAPI development after the implementation of provider education as well as increased mobilization with evaluation of patients’ backs with mirrors and placement of soft silicone foam dressings.

This study has several limitations. There is a low incidence of HAPIs in ECMO patients at the authors’ hospital, and the data are limited to a single center. With the cohorts being so low in number, the authors were not able to determine a statistically significant difference; thus, it is possible that other factors contributed to the decreased rate of HAPI formation in this patient population. The interventions adopted appeared to have worked in this environment as shown with a decrease to 0% HAPI development; however, it is possible that this incidence is so low to begin with that it was not in fact these improvements that altered the incidence. Additionally, a possibility exists for a Hawthorne effect, since after the implementation of a new protocol there may be increased awareness of providers being evaluated for performance. Also, because these quality improvement efforts were implemented at only one institution, the authors cannot speak to their generalizability; however, they do want to highlight the importance of continued provider education. Lastly, by excluding stage 1 and 2 pressure injuries from the inclusion criteria, the authors were limited in their complete evaluation of all pressure injuries and therefore likely underestimated the overall pressure injury rate.

Although a 4.2% rate of HAPI in pediatric patients on ECMO is relatively low, the goal should be a rate of 0%. After the implementation of ICU provider education and the addition of placing soft silicone foam dressings and using mirrors to examine patients’ backs, there were no HAPIs in pediatric ECMO patients at our institution. We plan to continue our education and to monitor the HAPI rate, specifically in this ECMO population. Our goal HAPI incidence rate is 0%, and we will not stop improving until this rate is maintained for an extended period.

Dr. Jackson is a pediatric surgery research fellow, Department of Surgery, University of California Davis, Sacramento, CA. Dr. Kirkland-Kyhn is the director of the wound care program at the University of California Davis, Sacramento, CA. Laura Kenny is a clinical nurse and the ECLS coordinator at the University of California Davis, Sacramento, CA, Department of Pediatric Intensive Care. Dr. Beres is a pediatric surgeon at the University of California Davis, Sacramento, CA. Dr. Mateev is the medical director for the pediatric and pediatric cardiac intensive care units and the medical director of ECLS at the University of California Davis, Sacramento, CA. Address all correspondence to: Jordan E. Jackson, MD, University of California Davis, 2335 Stockton Blvd, Room 5107, Sacramento, CA 95817; email: jordanjackson829@gmail.com.