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Drowning-related Acute Respiratory Failure

RecruitingNAAges 1 Year - anyAllAssistance Publique Hopitaux De Marseille
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion 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. Exclusion Criteria: * 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.
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What it tests

  • Emergency Medical Service intervention : Oxygen Supply strategy
  • Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy
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Where

9 sites
Centre Hospitalier de la Côte Basque - Urgences
Bayonne, France
Groupe Hospitalier PELLEGRIN - SAMU-SMUR
Bordeaux, France
CH La Rochelle - Urgence
La Rochelle, France
Centre Hospitalier Côte de Lumière - SAMU/SMUR 85
Les Sables-d'Olonne, France
CHU Timone - APHM
Marseille, France
CHU de Montpellier - Hôpital Lapeyronie
Montpellier, France
CHU de Nantes - Urgences/SAMU
Nantes, France
CHU Nice Hôpital Pasteur
Nice, France

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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