Extended prone positioning for adults with severe ARDS on mechanical ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Human umbilical cord mesenchymal stem cell injection for moderate to severe ARDS

  This will test whether a single injection of human umbilical cord mesenchymal stem cells can help adults with moderate to severe ARDS that hasn't improved after standard treatment.

  Recruiting Phase 1/2 Changchun Tuohua Pharmaceutical Co., Ltd. · Wuhan, Hubei · NCT07413978

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.