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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05894291
Other study ID # DR220257/PROPOSE
Secondary ID IDRCB
Status Recruiting
Phase N/A
First received
Last updated
Start date November 24, 2023
Est. completion date December 2025

Study information

Verified date April 2024
Source University Hospital, Tours
Contact Guillaume FOSSAT
Phone 0033238651318
Email guillaume.fossat@chr-orleans.fr
Is FDA regulated No
Health authority
Study type Interventional

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.


Recruitment information / eligibility

Status Recruiting
Enrollment 334
Est. completion date December 2025
Est. primary completion date November 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
France UHT of Orléans Orléans

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Tours UNIVERSITY HOSPITAL, ORLEANS

Country where clinical trial is conducted

France, 

References & Publications (5)

ARDS Definition Task Force; Ranieri VM, Rubenfeld GD, Thompson BT, Ferguson ND, Caldwell E, Fan E, Camporota L, Slutsky AS. Acute respiratory distress syndrome: the Berlin Definition. JAMA. 2012 Jun 20;307(23):2526-33. doi: 10.1001/jama.2012.5669. — View Citation

Girard R, Baboi L, Ayzac L, Richard JC, Guerin C; Proseva trial group. The impact of patient positioning on pressure ulcers in patients with severe ARDS: results from a multicentre randomised controlled trial on prone positioning. Intensive Care Med. 2014 Mar;40(3):397-403. doi: 10.1007/s00134-013-3188-1. Epub 2013 Dec 19. — View Citation

Guerin C, Reignier J, Richard JC, Beuret P, Gacouin A, Boulain T, Mercier E, Badet M, Mercat A, Baudin O, Clavel M, Chatellier D, Jaber S, Rosselli S, Mancebo J, Sirodot M, Hilbert G, Bengler C, Richecoeur J, Gainnier M, Bayle F, Bourdin G, Leray V, Girard R, Baboi L, Ayzac L; PROSEVA Study Group. Prone positioning in severe acute respiratory distress syndrome. N Engl J Med. 2013 Jun 6;368(23):2159-68. doi: 10.1056/NEJMoa1214103. Epub 2013 May 20. — View Citation

Labeau SO, Afonso E, Benbenishty J, Blackwood B, Boulanger C, Brett SJ, Calvino-Gunther S, Chaboyer W, Coyer F, Deschepper M, Francois G, Honore PM, Jankovic R, Khanna AK, Llaurado-Serra M, Lin F, Rose L, Rubulotta F, Saager L, Williams G, Blot SI; DecubICUs Study Team; European Society of Intensive Care Medicine (ESICM) Trials Group Collaborators. Prevalence, associated factors and outcomes of pressure injuries in adult intensive care unit patients: the DecubICUs study. Intensive Care Med. 2021 Feb;47(2):160-169. doi: 10.1007/s00134-020-06234-9. Epub 2020 Oct 9. Erratum In: Intensive Care Med. 2021 Apr;47(4):503-520. — View Citation

Sud S, Friedrich JO, Taccone P, Polli F, Adhikari NK, Latini R, Pesenti A, Guerin C, Mancebo J, Curley MA, Fernandez R, Chan MC, Beuret P, Voggenreiter G, Sud M, Tognoni G, Gattinoni L. Prone ventilation reduces mortality in patients with acute respiratory failure and severe hypoxemia: systematic review and meta-analysis. Intensive Care Med. 2010 Apr;36(4):585-99. doi: 10.1007/s00134-009-1748-1. Epub 2010 Feb 4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Mortality at day 28 Mortality rate at day 28 Day 28 after randomization
Secondary In-hospital Mortality at day 90 In-hospital Mortality rate at day 90 Day 90 after randomization
Secondary Number of days without mechanical ventilation at D28 Ventilator Free days at day 28 Day 28 after randomization
Secondary 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
Secondary Length of hospital stay (censored at D90) Length of hospital stay after randomization (censored at D90) Day 90 after randomization
Secondary 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
Secondary 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
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