Clinical trial NCT05894291: Comparaison of Two Prone Position Techniques on Occurence of Pressure Sores in ICU
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Respiratory Distress Syndrome
Pressure Ulcers Stage III
Keywords: ARDS
Pressure Sores
Pressure Ulcer
Acute Respiratory Distress Syndrome
Prone Position
Swimmer Position
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
Collaborators: name: UNIVERSITY HOSPITAL, ORLEANS
First posted: 2023-06-08
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of stage 3 or higher pressure ulcers
timeFrame: Day 28 after randomization
Secondary outcomes:
measure: Mortality at day 28
timeFrame: Day 28 after randomization
measure: In-hospital Mortality at day 90
timeFrame: Day 90 after randomization
measure: Number of days without mechanical ventilation at D28
timeFrame: Day 28 after randomization
measure: Length of stay in intensive care unit (censored at Day 90)
timeFrame: Day 90 after randomization
measure: Length of hospital stay (censored at D90)
timeFrame: Day 90 after randomization
measure: Presence of ICU acquired weakness at discharge from ICU
timeFrame: Day 28 after randomization
measure: Occurrence of scapulohumeral joint dislocation during prone period
timeFrame: Day 28 after randomization
Other outcomes:
Locations:
city: Orléans
country: France
facility: UHT of Orléans
Study officials:
References:
citation: 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.
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.
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.
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.
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.