An interventional study of Swimmer Prone Position and Prone position with arms alongside the body in Acute Respiratory Distress Syndrome and Pressure Ulcers Stage III, sponsored by University Hospital, Tours. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University Hospital, Tours · Not applicable, Interventional, and Prevention
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:
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.
1,597 studies on the registry are indexed under Respiratory Distress Syndrome; 312 are open to participants now.
This study's enrollment of 334 is above the median of 60 across 961 interventional studies indexed under Respiratory Distress Syndrome.
Browse Respiratory Distress Syndrome studies →University Hospital, Tours is the lead sponsor of 304 studies on the registry; 78 are open to participants now.
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Exclusion Criteria:
Other: Swimmer Prone Position
Other: Prone position with arms alongside the body
Patients will be positioned with the head rotated. This rotation is followed by shoulder elevation/abduction, then 90° elbow flexion for the arm opposite to the head rotation. The hand is placed flat on the bed. A 60° to 90° flexion is performed on the hip homolateral to head rotation, combined with knee flexion. The position is changed to the mirror position every 4 hours.
The head will be positioned either straight or rotated to one side, depending on ICU habits. The arms are positioned symmetrically along the body, palms up. The lower limbs are positioned symmetrically and parallel, knees extended or slightly flexed if a cushion is used on the front of the feet. Head rotation, if applicable, is performed every 4 hours.
Occurrence of stage 3 or higher pressure ulcers
Percentage of patients who acquired at least one stage 3 or 4 pressure ulcer between day 1 (randomization) and day 28 according to the revised pressure injury staging system (Edsberg, J Wound Ostomy Cont Nurs, 2016). Death and resolution of ARDS will be considered as events in competition with the occurrence of a Stage 3 or higher pressure ulcer.
Time frame: Day 28 after randomization
Mortality at day 28
Mortality rate at day 28
Time frame: Day 28 after randomization
In-hospital Mortality at day 90
In-hospital Mortality rate at day 90
Time frame: Day 90 after randomization
Number of days without mechanical ventilation at D28
Ventilator Free days at day 28
Time frame: Day 28 after randomization
Length of stay in intensive care unit (censored at Day 90)
Length of stay in intensive care unit after randomization (censored at D90)
Time frame: Day 90 after randomization
Length of hospital stay (censored at D90)
Length of hospital stay after randomization (censored at D90)
Time frame: Day 90 after randomization
Presence of ICU acquired weakness at discharge from ICU
Rate of patients with ICU acquired weakness defined by MRC score less than 48 at ICU discharge
Time frame: Day 28 after randomization
Occurrence of scapulohumeral joint dislocation during prone period
Number of patients with at least one radiologically proven scapulohumeral dislocation during a prone position period
Time frame: Day 28 after randomization
Plan to share: No
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Respiratory Distress Syndrome→
University Hospital, Tours