NCT07126964 Extended Prone Positioning for Intubated ARDS
| NCT ID | NCT07126964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 800 participants |
| Start Date | 2025-10-18 |
| Primary Completion | 2027-10-18 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 800 participants in total. It began in 2025-10-18 with a primary completion date of 2027-10-18.
⚠ 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
Acute respiratory distress syndrome (ARDS) is an acutely induced respiratory failure characterised by the appearance of bilateral alveolar opacities on imaging and hypoxemia(1). Among strategies that have proved beneficial in terms of patient outcome, prone position (PP) is one associated with the greatest impact in terms of reduction in mortality, with PP sessions of 17h on average(2). The benefit of PP is to better homogenize the stress and strain applied to the lung by invasive ventilation. In a multicentric retrospective study involving COVID-19-related intubated ARDS patients, a strategy of extended PP, where PP was maintained for a median duration of 40 hours (h), was associated with increased survival compared to standard PP where each session lasted less than 24h(10). The main objective of this study is to investigate whether extended PP, defined as 40-hour PP sessions, can significantly reduce mortality of patients with invasively ventilated, severe ARDS, at day 28 after inclusion, compared to standard, 16-hour, PP sessions. The primary endpoint is all-cause mortality 28 days after inclusion. The study is a prospective, randomised, open-label, two-group parallel, multicenter trial comparing 40-hour extended PP to 16-hour standard PP in patients with moderate to severe ARDS. After inclusion, patients will be randomised either to standard PP, or extended PP. In the control arm, patients will be turned prone for 16-hour sessions. In the intervention arm, patients will be turned prone for 40h. In both groups, maintaining PP for up to an extra 8 hours will be permitted, allowing PP sessions to last 24 hours in the comparator group, and 48 hours in the intervention group. Inclusion criteria will be: severe ARDS, with ARDS defined according to the 2012 Berlin definition; and the severity defined as a PaO2/FiO2 ratio of \<150 mm Hg, with an FiO2 of ≥ 60% persisting for at least 4h after optimization of ventilatory setting. Exclusion criteria will be : PP during the same Intensive care unit ( 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 prompting study inclusion, spine instability, intracranial pressure \> 20 mmHg, severe brain injury, hemodynamic instability deemed to contraindicate PP by the physician in charge.
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
Contact & Investigator
Thaïs Walter, Dr
PRINCIPAL INVESTIGATOR
University Hospital Saint-Louis Lariboisière, APHP
Frequently Asked Questions
Who can join the NCT07126964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07126964 currently recruiting?
Yes, NCT07126964 is actively recruiting participants. Contact the research team at thais.walter@aphp.fr for enrollment information.
Where is the NCT07126964 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT07126964 clinical trial?
NCT07126964 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Thaïs Walter, Dr at University Hospital Saint-Louis Lariboisière, APHP. The trial plans to enroll 800 participants.