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Effects on Biotrauma of NMBAs and PP Association During ARDS

RecruitingNAAges 18 Years - anyAllAssistance Publique Hopitaux De Marseille
NCT06212492 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age \> 18 years * Written informed consent of proxy to the study participation * Invasive mechanical ventilation for ≤ 72 hours at inclusion * Criteria of moderate to severe ARDS according to the Berlin definition * Patients covered by or having the rights to social security Exclusion Criteria: * Pregnant or breast-feeding women, patients deprived of freedom or under legal authority * Patients having undergone previous PP sessions during the same stay * Patients who had already been curarized prior to inclusion * Patient currently receiving ECMO or any technique of extracorporeal CO2 removal at the time of inclusion * Patient with a contraindication to PP * Previous hypersensitivity or anaphylactic reaction to any NMBA * Chronic respiratory insufficiency with oxygen or long-term ventilation * SAPS II score at the time of enrollment \> 75 * Patients who are moribund or for whom limitations of active therapies have been decided.
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What it tests

  • NMBAs
  • Prone positioning
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Where

1 site
Service Médecine Intensive et Réanimation
Marseille, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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