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New treatment option for Drowning
Official title Drowning-related Acute Respiratory Failure
ClinicalTrials.gov ID: NCT06183827
What this study is testing
- What it's testing
- 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 Supply by face mask (15Liters/minutes) (control group).
- 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 1 and older
You may be able to join if
- 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...
- 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%;
You likely can't join if
- 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...
- Cardiac arrest or respiratory arrest ;
- Declared pregnancy or breastfeeding ;
- Patient under legal protection regime for adults.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bayonne, France
- Bordeaux, France
- La Rochelle, France
- Les Sables-d'Olonne, France
- Marseille, France
- Montpellier, France
- Nantes, France
- Nice, France
- Toulon, 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, 1 year and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bayonne, France; Bordeaux, France; La Rochelle, France; Les Sables-d'Olonne, France; Marseille, France; Montpellier, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.