Drowning-related Acute Respiratory Failure

NCT06183827 | Recruiting

• 1 other identifier: 2023-A01181-44
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 9

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).

Conditions

Drowning

Outcome Measures

Primary Outcomes (5)

• 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

• Glasgow Coma Scale

  Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Glasgow Coma Scale \< 13

  6 hours

• Cardiac arrest occurrence

  Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Cardiac arrest occurrence

  6 hours

• 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

• Aspiration

  Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Aspiration

  6 hours

Study Arms (2)

the Oxygen Supply strategy

ACTIVE COMPARATOR

Procedure: Emergency Medical Service intervention : Oxygen Supply strategy

the Continuous Positive Airway Pressure strategy

EXPERIMENTAL

Procedure: Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy

Interventions

Emergency Medical Service intervention : Oxygen Supply strategy PROCEDURE

During the 4-month period of control, the care teams will: \- Use Oxygen Supply by face mask (15Liters/minutes) from pre-hospital to intensive care unit admission until the 6th hour following the start of drowning care (Emergency Medical Service arrival at the scene). Indeed, current concepts of advanced prehospital care include the use of oxygen by face mask (15Liters/minutes) and intubation-Mechanical Ventilation in case of failure. The requirement of intubation-Mechanical Ventilation by the Emergency Medical Service (pre-hospital phase) or Intensive Care Unit (hospital phase) practitioners during this first 6 hours period will be left to the discretion of the practitioners in charge of the patient; \- Continue this strategy in the Intensive Care Unit until the Acute Respiratory Failure resolution allows a reduction of Oxygen Supply. The Oxygen Supply will be reduced progressively litter by litter each 12 hours period with maintenance of capillary saturation up to 92%.

the Oxygen Supply strategy

Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy PROCEDURE

During the 4-month period of experimentation, the care teams will: \- Use Non-Invasive Ventilation by Continuous Positive Airway Pressure (set between 8 to 10 cm H2O) from pre-hospital setting to Intensive Care Unit admission until the 6th hour following the start of drowning care (Emergency Medical Service arrival at the scene). The requirement of Mechanical Ventilation by the Emergency Medical Service (pre-hospital phase) or Intensive Care Unit (hospital phase) practitioners during this first 6 hours period will be left to the discretion of the practitioners in charge of the patient. \- Continue this strategy in the Intensive Care Unit until the Acute Respiratory Failure resolution allows a reduction of Non-Invasive Ventilation-Continuous Positive Airway Pressure. Non-Invasive Ventilation-Continuous Positive Airway Pressure support will be weaned progressively (left at practitioners' convenience) with maintenance of capillary O2 saturation up to 92%.

the Continuous Positive Airway Pressure strategy

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (9)

Centre Hospitalier de la Côte Basque - Urgences

Bayonne, France

RECRUITING

Groupe Hospitalier PELLEGRIN - SAMU-SMUR

Bordeaux, France

RECRUITING

CH La Rochelle - Urgence

La Rochelle, France

RECRUITING

Centre Hospitalier Côte de Lumière - SAMU/SMUR 85

Les Sables-d'Olonne, France

RECRUITING

CHU Timone - APHM

Marseille, 13005, France

NOT YET RECRUITING

CHU de Montpellier - Hôpital Lapeyronie

Montpellier, France

RECRUITING

CHU de Nantes - Urgences/SAMU

Nantes, France

RECRUITING

CHU Nice Hôpital Pasteur

Nice, France

RECRUITING

CHITS Hôpital Ste Musse

Toulon, 83053, France

RECRUITING

MeSH Terms

Conditions

Drowning

Condition Hierarchy (Ancestors)

Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Central Study Contacts

Pierre Michelet, MD

CONTACT

638741313; pierre.michelet@ap-hm.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open-label study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, prospective, cross-over cluster randomized study

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 28, 2023
• Study Start: July 24, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-02

Locations

FR (9)