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Completed

NCT Number: NCT05894291

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UHT of Orléans

Orléans, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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

  1. Mortality at day 28

    Time frame: Day 28 after randomization

    Mortality rate at day 28

  2. In-hospital Mortality at day 90

    Time frame: Day 90 after randomization

    In-hospital Mortality rate at day 90

  3. Number of days without mechanical ventilation at D28

    Time frame: Day 28 after randomization

    Ventilator Free days at day 28

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

    Time frame: Day 90 after randomization

    Length of stay in intensive care unit after randomization (censored at D90)

  5. Length of hospital stay (censored at D90)

    Time frame: Day 90 after randomization

    Length of hospital stay after randomization (censored at D90)

  6. Presence of ICU acquired weakness at discharge from ICU

    Time frame: Day 28 after randomization

    Rate of patients with ICU acquired weakness defined by MRC score less than 48 at ICU discharge

  7. Occurrence of scapulohumeral joint dislocation during prone period

    Time frame: Day 28 after randomization

    Number of patients with at least one radiologically proven scapulohumeral dislocation during a prone position period

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • University of New Orleans

Registry information

Official study 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.

Acronym: PROPOSE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 8, 2023
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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