Drowning-related Acute Respiratory Failure

Not Applicable

Not yet recruiting

• Conditions: Drowning

• Registration Number: NCT06183827
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Study Timeline

• Status Verified: 2023-12
• Study First Submitted: 2023-12-05
• Study First Submitted QC: 2023-12-13
• Last Update Submitted: 2023-12-13
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28
• Study Start: 2024-04
• Primary Completion: 2026-03
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 210

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Inability to improve oxygen saturation up than 92%	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	6 hours	Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Glasgow Coma Scale \< 13
Cardiac arrest occurrence	6 hours	Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Cardiac arrest occurrence
Systolic arterial pressure	6 hours	Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Systolic arterial pressure \< 90 mmHg
Aspiration	6 hours	Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Aspiration

Trial Locations

Locations (1)

CHU Timone - APHM; 🇫🇷 Marseille, France