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

Sponsor

University Hospital, Tours (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05894291

Collaborator

UNIVERSITY HOSPITAL, ORLEANS (Other)

334

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief 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:

prone , with arms alongside the body
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.

Condition or Disease	Intervention/Treatment	Phase
Acute Respiratory Distress Syndrome Pressure Ulcers Stage III	Other: Swimmer Prone Position Other: Prone position with arms alongside the body	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

334 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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.

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Nov 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Swimmer Prone Position	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.
Active Comparator: Prone position with arms alongside the body	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.

Arm

Intervention/Treatment

Experimental: Swimmer Prone Position

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.

Active Comparator: Prone position with arms alongside the body

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.

Outcome Measures

Primary Outcome Measures

Occurrence of stage 3 or higher pressure ulcers [Day 28 after randomization]
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.

Secondary Outcome Measures

Mortality at day 28 [Day 28 after randomization]
Mortality rate at day 28
Mortality at day 90 [Day 90 after randomization]
Mortality rate at day 90
Number of days without mechanical ventilation at D28 [Day 28 after randomization]
Ventilator Free days at day 28
Length of stay in intensive care unit (censored at Day 90) [Day 90 after randomization]
Length of stay in intensive care unit after randomization (censored at D90)
Length of hospital stay (censored at D90) [Day 90 after randomization]
Length of hospital stay after randomization (censored at D90)
Presence of ICU acquired weakness at discharge from ICU [Day 28 after randomization]
Rate of patients with ICU acquired weakness defined by MRC score less than 48 at ICU discharge
Occurrence of scapulohumeral joint dislocation during prone period [Day 28 after randomization]
Number of patients with at least one radiologically proven scapulohumeral dislocation during a prone position period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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