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

NCT05894291 | Recruiting

• 2 other identifiers: DR220257/PROPOSEIDRCB
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

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. 1.prone , with arms alongside the body
2. 2.prone, swimmer's position

Conditions

Acute Respiratory Distress Syndrome; Pressure Ulcers Stage III

Keywords

ARDS; Pressure Sores; Pressure Ulcer; Acute Respiratory Distress Syndrome; Prone Position; Swimmer Position

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Mortality at day 28

  Day 28 after randomization

• In-hospital Mortality at day 90

  Day 90 after randomization

• Number of days without mechanical ventilation at D28

  Day 28 after randomization

• Length of stay in intensive care unit (censored at Day 90)

  Day 90 after randomization

• Length of hospital stay (censored at D90)

  Day 90 after randomization

Study Arms (2)

Swimmer Prone Position

EXPERIMENTAL

Other: Swimmer Prone Position

Prone position with arms alongside the body

ACTIVE COMPARATOR

Other: Prone position with arms alongside the body

Interventions

Swimmer Prone Position OTHER

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.

Swimmer Prone Position

Prone position with arms alongside the body OTHER

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.

Prone position with arms alongside the body

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Health insurance coverage

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead
• UNIVERSITY HOSPITAL, ORLEANS: collaborator

Study Sites (1)

UHT of Orléans

Orléans, France

RECRUITING

Related 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.

  PMID: 22797452 BACKGROUND

• 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.

  PMID: 23688302 BACKGROUND

• 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.

  PMID: 33034686 BACKGROUND

• 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.

  PMID: 24352484 BACKGROUND

• 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.

  PMID: 20130832 BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome; Pressure Ulcer

Interventions

Prone Position

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Guillaume FOSSAT

CONTACT

0033238651318; guillaume.fossat@chr-orleans.fr

Yosra DRIDI

CONTACT

0033247479792; y.abderrahmen@chu-tours.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: November 24, 2023
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)