Extended prone positioning for adults with severe ARDS on mechanical ventilation
Extended Prone Positioning for Intubated ARDS: a Randomized Controlled Trial
This trial tests whether keeping intubated adults with severe ARDS prone for about 40 hours per session lowers deaths compared with the standard ~16-hour sessions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT07126964 on ClinicalTrials.gov |
What this trial studies
This interventional trial compares two prone-positioning strategies in invasively ventilated adults with severe ARDS: extended 40-hour prone sessions versus standard 16-hour sessions. Eligible ICU patients within five days of intubation who meet Berlin criteria and protective ventilation targets are enrolled and assigned to one of the two prone-duration approaches while other ventilation parameters are managed per protocol. The primary outcome is mortality at day 28, with monitoring for ventilator-associated complications and safety events. The trial builds on retrospective data suggesting longer prone duration may improve survival and seeks to test that effect prospectively.
Who should consider this trial
Good fit: Adults (≥18) in the ICU on invasive ventilation for up to 5 days who meet the 2012 Berlin criteria for ARDS and have PaO2/FiO2 ≤150 mmHg on FiO2 ≥60% while on protective ventilation settings are the intended participants.
Not a fit: Patients already proned during the same ICU stay, those on ECMO, or those with contraindications to prolonged prone positioning are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, extended prone sessions could reduce 28-day mortality and decrease ventilator-induced lung injury in severe ARDS patients.
How similar studies have performed: Previous randomized trials established benefit for standard prolonged prone sessions (~16 hours, e.g., PROSEVA), and a multicenter retrospective COVID-19 cohort reported better survival with median ~40-hour sessions, but randomized evidence for extended-duration proning is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Age of 18 years * Admitted to ICU. * Under invasive ventilation for a maximum of 5 days. * Meeting the 2012 Berlin criteria for ARDS * Protective ventilation at time of inclusion : 1. Plateau pressure \< 35 cm of H2O at the time of screening 2. VT ≤ 8 ml/kg PBW on all nurse's charts before inclusion 3. PEEP ≥ 5 cm H2O on all nurse's charts before inclusion c. Twice daily blood gas while FiO2 ≥ 60% before inclusion * PaO2/FiO2 ≤ 150 mmHg with FiO2 ≥ 60% and Spo2 between 92 and 96% after optimization by setting PEEP to 10 mmHg, sedation levels optimization and, if necessary, administration of neuromuscular blockers to ensure patient-ventilator synchrony, with VT ≤ 8 ml/kg PBW and Pplateau \< 30 cm H2O. Exclusion Criteria: * PP during the same ICU stay and before inclusion, ECMO before PP, arterio-venous ECMO * persistent PaO₂/FiO₂ ratios \<150 mm Hg, with FiO2 ≥ 60% on all arterial blood gases collected over a 24-hour period without this prompting study inclusion * Spine instability, intracranial pressure \> 20 mmHg, severe brain injury, hemodynamic instability deemed to contraindicate PP by the physician in charge * Home oxygen supplementation * Care limited to comfort measures only * Inclusion in another interventional study including mechanically ventilated patients, which intervention concerns PP and for which mortality à D28 or D30 is the main outcome studied. * Already included in PROSECO * Pregnancy, subject deprived of freedom, Person under conservartorship, no insurance * Refusal to participate expressed by the patient or his/her healthcare proxy or a close relative if present
Where this trial is running
Paris
- Hôpital Saint-Louis — Paris, France (Recruiting)
Study contacts
- Principal investigator: Thaïs Walter, Dr — University Hospital Saint-Louis Lariboisière, APHP
- Study coordinator: Thaïs Walter, Dr
- Email: thais.walter@aphp.fr
- Phone: 33. (0)6. 29. 81. 50. 92
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.