Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06647784

Lateral Positioning and Prone Positioning in ARDS Patients

Led by Centre Hospitalier de Bastia · Updated on 2025-05-15

20

Participants Needed

2

Research Sites

100 weeks

Total Duration

On this page

Sponsors

C

Centre Hospitalier de Bastia

Lead Sponsor

C

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Collaborating Sponsor

AI-Summary

What this Trial Is About

Lateral (30°) and alternating positioning (change of side every 30 minutes) carried out on specific beds, could be an alternative or complement to prone positioning (PP) in ARDS patients. The combination of lateralization in prone position has not been studied. The dynamic created by lateralization could allow better overall ventilation during PP, thus making it possible to further improve oxygenation. The main objective of this prospective, bicentric, open, single group study with repeated measures will be to demonstrate that the addition of repeated 30-minute periods of 30° lateralization improves pulmonary aeration in the supine and prone positions in patients with moderate to severe ARDS.

CONDITIONS

Official Title

Lateral Positioning and Prone Positioning in ARDS Patients

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age of at least 18 years
  • ARDS evolving for less than 5 days with a PaO2/FiO2 ratio below 150 after optimization of PEEP, curarization, and no prior use of prone positioning since intubation
  • Written consent obtained from the patient or authorized representative
  • Beneficiary of health insurance coverage
  • Ability to participate in other studies that do not interfere with this study's evaluation criteria
Not Eligible

You will not qualify if you...

  • Refusal to participate
  • Pregnant, parturient, or breastfeeding women
  • Intracranial pressure above 30 mm Hg or cerebral perfusion pressure below 60 mmHg
  • Severe chronic respiratory disease requiring home oxygen or mechanical ventilation (except CPAP/BIPAP for sleep apnea)
  • Chronic interstitial lung diseases
  • Patients on ECMO
  • Weight over 100 kg
  • Severe liver disease with Child-Pugh score 12-15
  • Pneumothorax
  • SAPS II score above 75 at inclusion
  • Unstable spinal fracture
  • Contraindications to electrical impedance tomography (pacemaker, implantable defibrillator, skin lesions between 4th and 5th ribs)
  • Withdrawal or withholding treatment decision (except for ECMO)
  • Any other condition interfering with study evaluation
  • Legal protection measures (guardianship, curatorship)
  • Detained persons by judicial or administrative decision
  • Inability to complete the 25-hour intervention due to worsening condition requiring ECMO, death, or organizational problems

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Bastia General Hospital

Bastia, France, France, 20604

Actively Recruiting

2

North Hospital Marseille

Marseille, France, France, 13915

Actively Recruiting

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Research Team

L

Laurent Papazian, MD,PHD

CONTACT

A

Antoine Faure, PH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

1

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