Comparaison of Two Prone Position Techniques on Occurence of Pressure Sores in ICU — PROPOSE  

Acute Respiratory Distress Syndrome Clinical Trial

Official title: Evaluation Two Different Prone Position Techniques on the Occurrence of Pressure Sores in Patients With Invasive Mechanical Ventilation With Acute Respiratory Distress Syndrome in the Intensive Care Unit : a Multicenter, Prospective Randomized Controlled Trial.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Pressure Ulcer
• Pressure Ulcers Stage III
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

• NCT number: NCT05894291
• Study type: Interventional
• Source: University Hospital, Tours
• Contact: Guillaume FOSSAT
• Phone: 0033238651318
• Email: guillaume.fossat@chr-orleans.fr
• Status: Recruiting
• Phase: N/A
• Start date: November 24, 2023
• Completion date: December 2025