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New treatment option for Moderate to Severe Acute Respiratory Distress Syndrome
Official title Effects on Biotrauma of NMBAs and PP Association During ARDS
ClinicalTrials.gov ID: NCT06212492
What this study is testing
What is NMBAs?
NMBAs is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for moderate to severe acute respiratory distress syndrome.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Marseille, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Marseille, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.