Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 210
- Locations
- 9
- Primary Endpoint
- Inability to improve oxygen saturation up than 92%
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Open-label study
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Procedure)
the Continuous Positive Airway Pressure strategy
Intervention: Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy (Procedure)
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
Secondary Outcomes
No secondary outcomes reported