Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure
Overview
- Phase
- Not Applicable
- Intervention
- Emergency Medical Service intervention : Oxygen Supply strategy
- Conditions
- Drowning
- Sponsor
- Assistance Publique Hopitaux De Marseille
- Enrollment
- 210
- Locations
- 9
- Primary Endpoint
- Inability to improve oxygen saturation up than 92%
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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 Supply by face mask (15Liters/minutes) (control group).
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-Continuous Positive Airway Pressure (Arm 1) * Control group: Oxygen Supply by face mask (Arm 2) 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: * The acute respiratory failure related to drowning in salt or fresh water presented the same clinical pathway and prognosis ; * Most victims with drowning related acute respiratory failure do no present hemodynamic instability ; * If the oxygenation is rapidly improved, neurological status is also maintained in acute respiratory failure victims ; * Pediatric and adult presentations are similar. 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: * Fast recovery of acute respiratory failure in 24h * Retrospective publications showing that the benefit of non-invasive ventilation probably based on continuous positive airway pressure mode * Easy implementation of continuous positive airway pressure in the pre-hospital setting (adults, children, newborns) * Complexity of mechanical ventilation in pre-hospital setting. Our working hypothesis is the efficacy of early use of non-invasive ventilation-continuous positive airway pressure in drowning related acute respiratory failure.
Investigators
Eligibility Criteria
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.
Arms & Interventions
the Oxygen Supply strategy
Intervention: Emergency Medical Service intervention : Oxygen Supply strategy
the Continuous Positive Airway Pressure strategy
Intervention: Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy
Outcomes
Primary Outcomes
Inability to improve oxygen saturation up than 92%
Time Frame: 6 hours
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;
Glasgow Coma Scale
Time Frame: 6 hours
Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Glasgow Coma Scale \< 13
Cardiac arrest occurrence
Time Frame: 6 hours
Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Cardiac arrest occurrence
Systolic arterial pressure
Time Frame: 6 hours
Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Systolic arterial pressure \< 90 mmHg
Aspiration
Time Frame: 6 hours
Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Aspiration