Drowning-related Acute Respiratory Failure

Drowning Clinical Trial

— CPAPDROWNING  

Official title:

Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06183827
• Other study ID #: 2023-A01181-44
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: March 2026

Study information

• Verified date: December 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Pierre Michelet, MD
• Phone: 638741313
• Email: pierre.michelet[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: March 2026
• Est. primary completion date: March 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year and older

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.

Related Conditions & MeSH terms

• Drowning
• Respiratory Insufficiency

Intervention

Procedure:
• Emergency Medical Service intervention
Facing an Acute Respiratory Failure, emergency medical service must rapidly choose between oxygen supply by face mask (15Liters/minutes), Mechanical Ventilation or non-invasive ventilation. Mechanical Ventilation as non-invasive ventilation present interest and side arms as oxygen supply by face mask (15Liters/minutes) for hypoxemia control.

Locations

Country	Name	City	State
France	CHU Timone - APHM	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inability to improve oxygen saturation up than 92%	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;	6 hours
Primary	Glasgow Coma Scale	Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Glasgow Coma Scale < 13	6 hours
Primary	Cardiac arrest occurrence	Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Cardiac arrest occurrence	6 hours
Primary	Systolic arterial pressure	Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Systolic arterial pressure < 90 mmHg	6 hours
Primary	Aspiration	Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Aspiration	6 hours