Comparing lateral and prone positioning in ARDS patients
Effect of Lateralization Before and During Prone Position on Pulmonary Aeration During ARDS
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier de Bastia Academic / other |
| Locations | 2 sites (Bastia, France and 1 other locations) |
| Trial ID | NCT06647784 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bastia, France and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.