Extended Prone Positioning for Intubated ARDS

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Aug 13, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment approach for people with severe acute respiratory distress syndrome (ARDS), a serious lung condition that makes it hard to breathe and often requires a breathing machine (ventilator). The trial is looking at whether keeping patients lying on their stomachs (a position called prone positioning) for a longer time—about 40 hours at once—helps them survive better compared to the usual shorter sessions of about 16 hours. Lying on the stomach can help improve lung function and oxygen levels in patients on ventilators.

To join the study, patients need to be adults (18 or older) who are in the intensive care unit (ICU) on a breathing machine for no more than 5 days, with a certain level of severe lung difficulty defined by oxygen measurements. Patients who have certain health issues like spine instability, brain injury, or very low blood pressure might not be eligible. If enrolled, participants will be randomly assigned to either the standard treatment (16 hours prone) or the longer treatment (40 hours prone). Both groups might have their prone position extended by a few hours if needed. The main goal is to see if the longer prone sessions can reduce the chance of death within 28 days. This study is important because it could help improve care and outcomes for people with severe lung problems needing ventilators.

Gender

ALL

Eligibility 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