Using prone positioning to treat acute respiratory distress syndrome
Physiological Study of Prone Position in Acute Respiratory Failure Syndrome
This study tests if lying face down can help people with severe breathing problems from Acute Respiratory Distress Syndrome feel better and improve their chances of recovery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Colombes) |
| Trial ID | NCT06061796 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of prone positioning on patients suffering from Acute Respiratory Distress Syndrome (ARDS) with a PaO2/FiO2 ratio less than 150 mmHg. Patients will be ventilated according to standard care protocols, and their response to prone positioning will be monitored through arterial blood gas measurements at various intervals. The study aims to optimize ventilation settings and assess the impact of prolonged prone positioning on patient outcomes, particularly mortality rates. The protocol adheres to established guidelines and includes additional treatments as necessary.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with ARDS and a PaO2/FiO2 ratio below 150 mmHg who are invasively ventilated.
Not a fit: Patients with uncontrolled intracranial hypertension, unstable spinal fractures, or those who have previously undergone two prone position sessions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates in patients with ARDS.
How similar studies have performed: Previous studies, such as the PROSEVA study, have shown that prolonged prone positioning can reduce mortality in ARDS patients, indicating that this approach has been successful in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patient with with ARDS with a P/F ratio \< 150 mm Hg regardless of etiology * invasive ventilated patient * indication for DV placement determined by the treating practitioner * BMI≥ 18 kg/m² * Affiliated to social security Exclusion Criteria: * Patients who have already undergone two prone position sessions * Pregnant women * Refusal to participate in the research * Patients under guardianship and trusteeship * Patients under State Medical Assistance (AME) * Uncontrolled intracranial hypertension * Unstable spinal fracture * Hemodynamic instability defined by MAP \< 65 mmHg * Presence of a pacemaker * Presence of an implantable defibrillator * Unresolved pneumothorax or bronchopleural fistula
Where this trial is running
Colombes
- Louis Mourier Hospital — Colombes, France (Recruiting)
Study contacts
- Principal investigator: Jean Damien Ricard, MD/PHD — Louis Mourier (AP-HP)
- Study coordinator: Jean Damien Ricard, MD/PHD
- Email: jean-damien.ricard@aphp.fr
- Phone: 01 47 60 61 62
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.