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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Acute Respiratory Distress Syndrome, Pressure Ulcers Stage III

Intervention / Treatment
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* Other: Swimmer Prone Position
* Other: Prone position with arms alongside the body


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Swimmer Prone Position<br> | Other: Swimmer Prone Position<br>* 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.<br>|
| Active Comparator: Prone position with arms alongside the body<br> | Other: Prone position with arms alongside the body<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 28 after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality at day 28 | Mortality rate at day 28 | Day 28 after randomization | 
| Mortality at day 90 | Mortality rate at day 90 | Day 90 after randomization | 
| Number of days without mechanical ventilation at D28 | Ventilator Free days at day 28 | 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) | Day 90 after randomization | 
| Length of hospital stay (censored at D90) | Length of hospital stay after randomization (censored at D90) | 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 | 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 | Day 28 after randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, Pressure Sores, Pressure Ulcer, Acute Respiratory Distress Syndrome, Prone Position, Swimmer Position