Comparaison of Two Prone Position Techniques on Occurence of Pressure Sores in ICU (NCT05894291) | Clinical Trial Compass
CompletedNot Applicable
Comparaison of Two Prone Position Techniques on Occurence of Pressure Sores in ICU
France334 participantsStarted 2023-11-24
Plain-language summary
Acute respiratory distress syndrome (ARDS) is a diffuse inflammation of the lungs that occurs in a variety of diseases. According to the Berlin definition, ARDS is characterized by diffuse lung damage in patients with predisposing factors. Understanding the physiology of ARDS has led to improved ventilatory management, which must be protective to ensure adequate oxygenation and CO2 clearance. Prone position (PP) is a technique that can reduce mortality in patients with severe ARDS. PP results in a more homogeneous distribution of pulmonary stress and strain, helping to protect the lung against ventilator-induced lung injury (VILI). It also increases the PaO2/FiO2 (P/F) ratio, improves the pulmonary ventilation-perfusion ratio, decreases PaCO2 and promotes ventilation of the dorsal lung regions. This technique should be offered to all patients with severe ARDS for 16 consecutive hours, to improve survival and weaning success from mechanical ventilation. However, PP has adverse effects. A meta-analysis showed an increased risk of pressure sores, possibly linked to generalized acute inflammation associated with significant cytokine discharge and diffuse lesions of the vascular endothelium. PP also increased the risk of obstruction and displacement of the endotracheal tube. Final positioning in PP, (i.e., the position imposed on the patient for the duration of the PP session) varies from one ICU to another, and is rarely described in scientific articles. There are two main variants:
1. prone , with arms alongside the body
2. prone, swimmer's position
The aim of our study is to show that the "swimmer" PP reduces the occurrence of stage 3 or higher pressure sores, compared with the "arms alongside the body" PP (standard care) at Day 28 post inclusion.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Intubated patient on invasive mechanical ventilation with moderate to severe acute respiratory distress syndrome according to the BERLIN classification with a P/F ratio \< 150, requiring prone position.
* Express consent of the patient or representative or in the absence of this, emergency inclusion procedure
* Health insurance coverage
Exclusion Criteria:
* Patient with 2 (or more) Prone position sessions
* Patient in whom one of the two positions could not be achieved: (Joint limitation; Neck size that would prevent head rotation; Orthopaedic spinal or segmental trauma; BMI greater than 45)
* Presence of stage 2 or higher pressure ulcers on the anterior parts of the body at screening
* Presence of extracorporeal membrane oxygenation (ECMO)
* Patient already included in the study
* Pregnant or breastfeeding woman
* Patient under legal protection
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared two different techniques for positioning patients face-down (prone) in the ICU — can you explain what those two techniques are and whether either one is already being used in my care?
2Since this study specifically tracked whether patients developed stage 3 or higher pressure ulcers during prone positioning, what did it find, and how does that affect how your team protects my skin if I need to be placed face-down?
3The trial is now completed — does that mean the results are available, and if so, have those findings changed how your ICU team approaches prone positioning for ARDS patients like me?
4Prone positioning is physically demanding and carries risks beyond pressure ulcers — given what this trial was measuring, what other complications should I be aware of if prone positioning becomes part of my treatment?
5If the evidence from this trial favors one technique over the other for preventing serious pressure injuries, is your hospital equipped to use the safer approach, or are there practical limitations I should know about?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.