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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Tours
- Enrollment
- 334
- Locations
- 2
- Primary Endpoint
- Occurrence of stage 3 or higher pressure ulcers
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Swimmer Prone Position
Intervention: Swimmer Prone Position (Other)
Prone position with arms alongside the body
Intervention: Prone position with arms alongside the body (Other)
Outcomes
Primary Outcomes
Occurrence of stage 3 or higher pressure ulcers
Time Frame: 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 Outcomes
- In-hospital Mortality at day 90(Day 90 after randomization)
- Length of stay in intensive care unit (censored at Day 90)(Day 90 after randomization)
- Presence of ICU acquired weakness at discharge from ICU(Day 28 after randomization)
- Occurrence of scapulohumeral joint dislocation during prone period(Day 28 after randomization)
- Mortality at day 28(Day 28 after randomization)
- Number of days without mechanical ventilation at D28(Day 28 after randomization)
- Length of hospital stay (censored at D90)(Day 90 after randomization)