Comparing lateral and prone positioning in ARDS patients
Official title: Effect of Lateralization Before and During Prone Position on Pulmonary Aeration During ARDS
Run by Centre Hospitalier de Bastia · NCT06647784 · Data updated 2026-11-12
This study is testing if changing the position of patients with severe lung issues can help them breathe better and get more oxygen.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Centre Hospitalier de Bastia Academic / other |
| Locations | 2 sites (Bastia, France and 1 other locations) |
| Status | Recruiting |
| Started | November 26, 2024 |
| Main results expected | January 31, 2026 |
| Study ends | October 31, 2026 |
| Registry record updated | May 15, 2025 |
| Trial ID | NCT06647784 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with ARDS evolving for less than 5 days and a PaO2/FiO2 ratio below 150.
✕Probably not a fit
Patients with severe chronic respiratory diseases requiring home oxygen therapy or mechanical ventilation, as well as those with high intracranial pressure, will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of lateral positioning (30°) and alternating positioning on pulmonary aeration in patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS). It aims to determine if adding lateralization during prone positioning can enhance overall ventilation and improve oxygenation. The study will measure changes in pulmonary aeration using electrical impedance tomography and assess gas exchange parameters. It is a bicentric, open-label study with repeated measures to evaluate the effectiveness of this positioning strategy.
Why it matters
Potential benefit: If successful, this approach could lead to improved oxygenation and ventilation in ARDS patients, potentially enhancing their recovery.
How similar studies have gone: While the combination of lateralization and prone positioning has not been extensively studied, similar approaches in positioning have shown promise in improving outcomes in ARDS patients.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria: * Age of at least 18 years * ARDS evolving for less than 5 days with a PaO2/FiO2 ratio (P/F ratio) \< 150 after optimization of PEEP (P/V curve, R/I ratio), curarization and without prior use of the PP since orotracheal intubation. * Obtained written consent of the patient, one of his relatives or the previously designated trusted person. As soon as possible, the patient will be informed and his written consent will be obtained * Beneficiary of health insurance coverage * Possibility of participating in any other studies whose evaluation criteria do not interfere with those of the study Non-inclusion criteria: Patients with at least one of the following criteria will not be eligible: * Refusal to participate * Pregnant, parturient or breastfeeding women * Intracranial pressure \> 30 mm Hg or cerebral perfusion pressure \< 60 mmHg * Severe chronic respiratory disease with oxygen therapy or mechanical ventilation at home (except CPAP/BIPAP for obstructive sleep apnea) * Chronic interstitial lung diseases * Patients on ECMO * Weight \> 100 kg * Severe liver disease Child-Pugh score 12-15 * Pneumothorax * SAPS II score \> 75 at inclusion * Unstable spinal fracture * Contraindications to EIT (pacemaker, implantable defibrillator, skin lesions between the 4th and 5th ribs). * Withdrawal (except for ECMO) or witholding treatment decision * Any other reason which, according to the investigator, could interfere with the evaluation of the study objectives * Person under legal protection measure (guardianship, curatorship, etc.) * Person deprived of liberty by a judiciary or administrative decision Exclusion criteria: \- Patients who will be unable to complete the 25-hour intervention due to worsening requiring ECMO, death or organizational problems will be excluded from the analysis.
Where it's running
-
Bastia General Hospital
Bastia, France, France Recruiting -
North Hospital Marseille
Marseille, France, France Recruiting
Study contacts
- Study coordinator: Laurent Papazian, MD,PHD
- Email: laurent.papazian@ch-bastia.fr
- Phone: 0495591039
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.