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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).
Open-label, multicenter, prospective, cross-over cluster randomized (ratio 1:1), conducted in 16 Emergency Medical Service centers in France :
Drowning-related acute respiratory failure has important clinical consequences (4 to 18% mortality). No national/international medical consensus exist for its management.
Our team has successively demonstrated that:
Facing an acute respiratory failure, emergency medical service must rapidly choose between oxygen supply by face mask (15 liters /minutes), mechanical ventilation or non-invasive ventilation. mechanical ventilation as non-invasive ventilation present interests and side arms. No comparative study has been conducted between these strategies. The arguments for non-invasive ventilation use specifically in a continuous positive airway pressure mode are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| the Oxygen Supply strategy | Active Comparator |
| |
| the Continuous Positive Airway Pressure strategy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emergency Medical Service intervention : Oxygen Supply strategy | Procedure | During the 4-month period of control, the care teams will: - Use Oxygen Supply by face mask (15Liters/minutes) from pre-hospital to intensive care unit admission until the 6th hour following the start of drowning care (Emergency Medical Service arrival at the scene). Indeed, current concepts of advanced prehospital care include the use of oxygen by face mask (15Liters/minutes) and intubation-Mechanical Ventilation in case of failure. The requirement of intubation-Mechanical Ventilation by the Emergency Medical Service (pre-hospital phase) or Intensive Care Unit (hospital phase) practitioners during this first 6 hours period will be left to the discretion of the practitioners in charge of the patient; - Continue this strategy in the Intensive Care Unit until the Acute Respiratory Failure resolution allows a reduction of Oxygen Supply. The Oxygen Supply will be reduced progressively litter by litter each 12 hours period with maintenance of capillary saturation up to 92%. |
| Measure | Description | Time Frame |
|---|---|---|
| Inability to improve oxygen saturation up than 92% | Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Inability to improve oxygen saturation up than 92% despite the ventilatory strategy used; | 6 hours |
| Glasgow Coma Scale | Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Glasgow Coma Scale < 13 | 6 hours |
| Cardiac arrest occurrence | Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Cardiac arrest occurrence | 6 hours |
| Systolic arterial pressure | Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Systolic arterial pressure < 90 mmHg | 6 hours |
| Aspiration | Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Aspiration | 6 hours |
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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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pierre Michelet, MD | Contact | 638741313 | +33 | pierre.michelet@ap-hm.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier de la Côte Basque - Urgences | Recruiting | Bayonne | France |
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| ID | Term |
|---|---|
| D004332 | Drowning |
| ID | Term |
|---|---|
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014947 | Wounds and Injuries |
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Multicenter, prospective, cross-over cluster randomized study
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Open-label study
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|
| Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy | Procedure | During the 4-month period of experimentation, the care teams will: - Use Non-Invasive Ventilation by Continuous Positive Airway Pressure (set between 8 to 10 cm H2O) from pre-hospital setting to Intensive Care Unit admission until the 6th hour following the start of drowning care (Emergency Medical Service arrival at the scene). The requirement of Mechanical Ventilation by the Emergency Medical Service (pre-hospital phase) or Intensive Care Unit (hospital phase) practitioners during this first 6 hours period will be left to the discretion of the practitioners in charge of the patient. - Continue this strategy in the Intensive Care Unit until the Acute Respiratory Failure resolution allows a reduction of Non-Invasive Ventilation-Continuous Positive Airway Pressure. Non-Invasive Ventilation-Continuous Positive Airway Pressure support will be weaned progressively (left at practitioners' convenience) with maintenance of capillary O2 saturation up to 92%. |
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| Groupe Hospitalier PELLEGRIN - SAMU-SMUR | Recruiting | Bordeaux | France |
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| CH La Rochelle - Urgence | Recruiting | La Rochelle | France |
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| Centre Hospitalier Côte de Lumière - SAMU/SMUR 85 | Recruiting | Les Sables-d'Olonne | France |
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| CHU Timone - APHM | Not yet recruiting | Marseille | 13005 | France |
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| CHU de Montpellier - Hôpital Lapeyronie | Recruiting | Montpellier | France |
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| CHU de Nantes - Urgences/SAMU | Recruiting | Nantes | France |
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| CHU Nice Hôpital Pasteur | Recruiting | Nice | France |
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| CHITS Hôpital Ste Musse | Recruiting | Toulon | 83053 | France |
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