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New treatment option for Acute Respiratory Distress Syndrome
Official title "Continuous Positive Airway Pressure on Venovenous extracorporeaL Membrane Oxygenation for Acute respIratory Distress syndrOme"
ClinicalTrials.gov ID: NCT06814340
What this study is testing
- What it's testing
- The CALMDOWN trial is a prospective, open-label, multicenter, comparative, controlled trial randomizing patients who received near apneic ventilation vs usual care on ECMO (ultra-protective lung ventilation). The study goal is to investigate the benefit of early apneic ventilation in the most severe forms of acute respiratory distress syndrome (ARDS) rescued by ECMO.
- Phase 3: a large, late-stage study
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
- Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h)...
- Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close...
- French Social security registration (except AME)
You likely can't join if
- Age \< 18
- Pregnancy or breastfeeding
- Initiation of VV-ECMO \> 48 h (maximum tolerance : +2h)
- Cardiac arrest with cumulated no flow time \>10 minutes before ECMO (within 48 hours prior to inclusion)
- Irreversible neurological pathology
- End-stage chronic lung disease
See the full eligibility criteria
- Severe acute respiratory distress syndrome refractory to conventional therapy placed on VV-ECMO support in the 48 hours (maximum tolerance : +2h) preceding inclusion.
- Obtain informed consent from a close relative or surrogate. According to the specifications of emergency inclusion, randomization without the close relative/surrogate consent could be performed if the patient is unable...
- French Social security registration (except AME)
- Age \< 18
- Pregnancy or breastfeeding
- Initiation of VV-ECMO \> 48 h (maximum tolerance : +2h)
- Cardiac arrest with cumulated no flow time \>10 minutes before ECMO (within 48 hours prior to inclusion)
- Irreversible neurological pathology
- End-stage chronic lung disease
- Contraindications for high PEEP level: untreated pneumothorax, barotrauma
- Irreversible ARDS with no hope for lung function recovery
- Patient moribund on the day of randomization, SAPS II \>90
- Liver cirrhosis (Child B or C)
- Lung transplantation
- Burns on more than 20 % of the body surface
- Participation in another treatment study with a similar primary endpoint (mortality, lung transplantation, or duration of ECMO) or being in the exclusion period at the end of a previous study
- Individuals under guardianship, or permanently legally incompetent adults
The study team makes the final eligibility decision.
Where it's taking place
- Bobigny, France
- Bordeaux, France
- Créteil, France
- Lyon, France
- Marseille, France
- Metz, France
- Nancy, France
- Orléans, France
- Paris, France
- Rennes, France
- Tours, 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 Bobigny, France; Bordeaux, France; Créteil, France; Lyon, France; Marseille, France; Metz, France and 5 more location(s). 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.