Effects of neuromuscular blocking agents and prone positioning on ARDS
Effects on Biotrauma of Combining Routine CURArization With Prone Positioning During Adult Acute Respiratory Distress Syndrome
This study tests if using certain medications and positioning patients on their stomachs can help people with severe breathing problems from ARDS survive better while on a ventilator.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique Hopitaux De Marseille Academic / other |
| Locations | 1 site (Marseille) |
| Trial ID | NCT06212492 on ClinicalTrials.gov |
What this trial studies
This study investigates the combined effects of neuromuscular blocking agents (NMBAs) and prone positioning (PP) on patients with moderate to severe acute respiratory distress syndrome (ARDS). It aims to evaluate whether these interventions can improve survival rates in patients who are mechanically ventilated. The study is particularly relevant given the differing recommendations between North American and French guidelines regarding the use of NMBAs in ARDS treatment. By analyzing the outcomes of patients receiving these therapies, the study seeks to clarify their effectiveness in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old who are experiencing moderate to severe ARDS and require invasive mechanical ventilation.
Not a fit: Patients who are pregnant, have chronic respiratory insufficiency, or have severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting the use of NMBAs in conjunction with prone positioning to improve survival rates in ARDS patients.
How similar studies have performed: Previous studies have shown mixed results regarding the effectiveness of NMBAs and prone positioning in ARDS, indicating that this approach is still under investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Marseille
- Service Médecine Intensive et Réanimation — Marseille, France (Recruiting)
Study contacts
- Study coordinator: Sami Hraiech, MD
- Email: sami.hraiech@ap-hm.fr
- Phone: 0491964358
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.