A Bundle of Interventions to Prevent Pressure Ulcers During Prone Position in Adult Patients With Acute Respiratory Distress Syndrome: Results of a French Stepped-Wedge Randomized Controlled Trial.

backgroundIn patients with moderate-to-severe acute respiratory distress syndrome, the frequency of pressure ulcers is higher in the prone position than in the supine position.

aimTo assess the effect of a bundle of interventions to prevent pressure ulcers in patients with acute respiratory distress syndrome prone. STUDY

designESCARD is a stepped-wedge prospective multicentre trial conducted in France that included patients with moderate-to-severe acute respiratory distress syndrome, intubated and with an indication for pronation. In the control period, patients received the routine means of each centre. In the experimental period, the bundle of specific standardized means included: eye protection with methylcellulose; strapped lower eyelids; 15° body inclination; specific cushions inserted between the mattress and head/thorax and knees/feet; head rotation every 4 h. The primary end-point was the occurrence of a new pressure ulcer at any location and stage in the anterior part of the body 7 days after inclusion. It was assessed from pictures taken in the supine position and independently analysed by two experts blinded to the allocated period.

resultsFrom 16 April 2018 to 3 December 2020 (with an interruption between 12 March and 15 July 2020 because of COVID pandemic), a total of 160 patients were included in 9 centres; 156 were analysed. At the first proning session, all 6 specific preventive means were implemented in 1.2% of the patients in the control period and 91.8% in the experimental period. At Day 7, 53 patients (63.9%) in the control versus 40 (54.8%) in the experimental period had a new pressure ulcer at any location and of any stage (odds ratio = 0.92; 95% confidence interval [0.39; 2.18]). There was a 42.8% discrepancy between the two experts.

conclusionsIn this prospective multicentre stepped-wedge trial, the bundle of interventions did not lead to a significant reduction in the frequency of new pressure ulcers in moderate-to-severe acute respiratory distress syndrome patients treated by prone position. RELEVANCE TO CLINICAL PRACTICE: The critical care nurses were able to manage patients enrolled in a complex trial up to its planned end. Even though negative, the study should encourage intensive care unit (ICU) nurses to better define the bundle of interventions including introducing other methods not used in the present study. ICU nurses should also assess the stage of pressure ulcers consistently over time. ICU nurses should consider further studies because pressure ulcer is a relevant issue of concern during the pronation in acute respiratory distress syndrome patients. If so, the new trial should include a larger number of ICUs.

trial registrationThe protocol was approved by an ethics committee (number 2017-A01449-44 on 7 October 2017) and was recorded in clinicaltrials.gov (NCT03125421).