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

NCT05894291 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2024-04-10

No results posted yet for this study

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.

Conditions

  • Acute Respiratory Distress Syndrome
  • Pressure Ulcers Stage III

Interventions

OTHER

Swimmer Prone Position

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.

OTHER

Prone position with arms alongside the body

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.

Sponsors & Collaborators

  • UNIVERSITY HOSPITAL, ORLEANS

    collaborator UNKNOWN

  • University Hospital, Tours

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-24
Primary Completion
2025-11-30
Completion
2025-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05894291 on ClinicalTrials.gov