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Study identifier: NCT06212492 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Effects on Biotrauma of NMBAs and PP Association During ARDS

Condition: Moderate to Severe Acute Respiratory Distress Syndrome  ·  Sponsor: Assistance Publique Hopitaux De Marseille

PhaseNA
Planned participants40
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

The improved survival of patients with acute respiratory distress syndrome (ARDS) over the last decades is related to the use of so-called "protective" mechanical ventilation. Two therapies have been shown to increase survival among the most hypoxemic patients (PaO2/FiO2 \< 150 mmHg): a continuous use of neuromuscular blocking agents (NMBAs) for 48 hours in the acute phase of ARDS and prone positioning (PP). NMBAs and PP are part of the latest guidelines from French ICU Society. However, North American guidelines recommend PP for patients with severe ARDS only but not NMBAs, given the results of the ROSE study which did not confirm the benefit on mortality demonstrated in the ACURASYS study. However, in the ROSE study, ventilatory strategy, use of NMBAs and PP were different from the ACURASYS study. Yet, NMBAs and PP are frequently associated in clinical practice, particularly with the COVID-19 pandemic, but also in randomized trials. In the PROSEVA study, almost all the patients (91%) received a continuous infusion of NMBAs during PP. Indeed, there is a common physiopathological rationale in both techniques: they favor the homogenization of transpulmonary pressures (TPP), reduce lung overdistension, Pendelluft effect and thus ventilator induced lung injury (VILI), in particular barotrauma and biotrauma. This reduction of biotrauma has been demonstrated for PP and NMBAs separately, but never by comparing the combined effect of the 2 techniques to each of them separately. Thi…

This description comes directly from the study's public registry record.

Talk to the study team

Sami Hraiech, MD  ·  0491964358  ·  sami.hraiech@ap-hm.fr

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Locations (1)

Service Médecine Intensive et RéanimationMarseille, FranceRecruiting

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Source record: clinicaltrials.gov/study/NCT06212492