Overview
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).
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.
Eligibility
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.
