Clinical trial NCT06183827: Drowning-related Acute Respiratory Failure
Official title: Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Drowning
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 210
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multicenter, prospective, cross-over cluster randomized study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Inability to improve oxygen saturation up than 92%
timeFrame: 6 hours
measure: Glasgow Coma Scale
timeFrame: 6 hours
measure: Cardiac arrest occurrence
timeFrame: 6 hours
measure: Systolic arterial pressure
timeFrame: 6 hours
measure: Aspiration
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: CHU Timone - APHM
Study officials:
References: