NCT06647784 Lateral Positioning and Prone Positioning in ARDS Patients
| NCT ID | NCT06647784 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier de Bastia |
| Condition | ARDS |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-11-26 |
| Primary Completion | 2026-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2024-11-26 with a primary completion date of 2026-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
laurent papazian, MD,PHD
STUDY DIRECTOR
Bastia General Hospital
Frequently Asked Questions
Who can join the NCT06647784 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ARDS. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06647784 currently recruiting?
Yes, NCT06647784 is actively recruiting participants. Contact the research team at laurent.papazian@ch-bastia.fr for enrollment information.
Where is the NCT06647784 trial being conducted?
This trial is being conducted at Bastia, France, Marseille, France.
Who is sponsoring the NCT06647784 clinical trial?
NCT06647784 is sponsored by Centre Hospitalier de Bastia. The principal investigator is laurent papazian, MD,PHD at Bastia General Hospital. The trial plans to enroll 20 participants.