Status:
NOT_YET_RECRUITING
Drowning-related Acute Respiratory Failure
Lead Sponsor:
Assistance Publique Hopitaux De Marseille
Conditions:
Drowning
Eligibility:
All Genders
1+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the Non-Invasive Ventilation-Continuous Positive Airway Pressure efficacy (experimental group) for drowning related Acute Respiratory Failure compared to Oxygen ...
Detailed Description
Open-label, multicenter, prospective, cross-over cluster randomized (ratio 1:1), conducted in 16 Emergency Medical Service centers in France : * Experimental group: Non-Invasive Ventilation-Continuou...
Eligibility Criteria
Inclusion
- Man/boy or woman/girl, 1yo and older.
- Subject suffering from drowning related-Acute Respiratory Failure (whatever the nature of water, salt or fresh) and benefiting from the Emergency Medical Service intervention;
- Acute Respiratory Failure defined as the presence of:
- Capillary O2 saturation \<92% upon Emergency Medical Service first clinical analysis at the drowning scene;
- Need for oxygen supply 15Liters/minutes to reach capillary O2 saturation ≥ 95%;
- Combination of Acute Respiratory Failure clinical signs: at least 1 of the following items: respiratory rate \>30/min, sternal or clavicular indrawing, abdominal breathing, cyanosis.
- Individual affiliated to or beneficiary of a French health insurance system;
- Individual with the ability to benefit from the two strategies (ambivalence clause);
- Adult Individual having signed written informed consent or child subject with an authorization of the parents.
Exclusion
- Individual with hypothermia ≤ 34°C ;
- Individual with neurological distress defined by a Glasgow Coma Scale \< 13 at first clinical assessment and during the first 15 minutes of care ;
- Individual with hemodynamic distress defined by a systolic blood tension \< 90 mmHg at first clinical assessment and during the first 15 minutes of care ;
- Cardiac arrest or respiratory arrest ;
- Declared pregnancy or breastfeeding ;
- Patient under legal protection regime for adults.
Key Trial Info
Start Date :
April 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT06183827
Start Date
April 1 2024
End Date
March 1 2026
Last Update
December 28 2023
Active Locations (1)
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1
CHU Timone - APHM
Marseille, France, 13005