Condition: Acute Respiratory Distress Syndrome · Sponsor: Assistance Publique - Hôpitaux de Paris
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 b…
This description comes directly from the study's public registry record.
Thaïs Walter, Dr · 33. (0)6. 29. 81. 50. 92 · thais.walter@aphp.fr
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| Hôpital Saint-Louis | Paris, France | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07126964