DrowningCPAPDROWNINGNCT06183827
Drowning-related Acute Respiratory Failure
A study testing Emergency Medical Service intervention : Oxygen Supply strategy and Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy in people with Drowning, run by Assistance Publique Hopitaux De Marseille at 9 sites in France.
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). Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Drowning
- What is being tested?
- Emergency Medical Service intervention : Oxygen Supply strategy and Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 9 sitesFrance
- Study dates
- 24 Jul 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
France9 sites, 9 recruiting
- Recruiting
Centre Hospitalier de la Côte Basque - Urgences
Bayonne
LABES, MD
- Recruiting
Groupe Hospitalier PELLEGRIN - SAMU-SMUR
Bordeaux
Bruno SIMONNET, MD
- Recruiting
CH La Rochelle - Urgence
La Rochelle
Ombeline SUSONG, MD
- Recruiting
Centre Hospitalier Côte de Lumière - SAMU/SMUR 85
Les Sables-d'Olonne
Stanislas BAWEJSKI, MD
- Not yet recruiting
CHU Timone - APHM
Marseille, 13005
Pierre Michelet, MD, 638741313 ext. +33, pierre.michelet@ap-hm.fr
- Recruiting
CHU de Montpellier - Hôpital Lapeyronie
Montpellier
Mustapha SEBBANE, MD
- Recruiting
CHU de Nantes - Urgences/SAMU
Nantes
Emmanuel MONTASSIER, MD
- Recruiting
CHU Nice Hôpital Pasteur
Nice
Céline OCCELLI, MD
- Recruiting
CHITS Hôpital Ste Musse
Toulon, 83053
Muriel Vergne, MD
About this study
Official title: Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure
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).
Read the 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.
- Conditions
- Drowning
- Being tested
- Emergency Medical Service intervention : Oxygen Supply strategy, Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy
- Medical subject headings
- Drowning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emergency Medical Service intervention : Oxygen Supply strategyProcedure or surgery
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%.
Emergency Medical Service intervention : Continuous Positive Airway Pressure strategyProcedure or surgery
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%.
| Study group | Role | What they receive |
|---|---|---|
| the Oxygen Supply strategy | Active comparator | Not described Receives: Procedure: Emergency Medical Service intervention : Oxygen Supply strategy |
| the Continuous Positive Airway Pressure strategy | Experimental | Not described Receives: Procedure: Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 6 hours
Glasgow Coma Scale
Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Glasgow Coma Scale < 13
Measured: 6 hours
Cardiac arrest occurrence
Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Cardiac arrest occurrence
Measured: 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
Measured: 6 hours
Aspiration
Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Aspiration
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start24 Jul 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DrowningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicenter, prospective, cross-over cluster randomized study
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06183827
- Sponsor's protocol ID
- 2023-A01181-44
- Acronym
- CPAPDROWNING
- Status last verified
- Feb 2026
- First submitted
- 5 Dec 2023
- Last updated
- 6 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Non-Invasive Ventilation/Continuous Positive Airway Pressure for Drowning-related Acute Respiratory Failure
- ClinicalTrials.gov ID
- NCT06183827
- Acronym / sponsor ID
- CPAPDROWNING / 2023-A01181-44
- Conditions
- Drowning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 24 Jul 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Multicenter, prospective, cross-over cluster randomized study
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Individual affiliated to or beneficiary of a French health insurance system;
- Individual with the ability to benefit from the two strategies (ambivalence clause);
Key exclusion criteria (6 listed)
- 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 ;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Emergency Medical Service intervention : Oxygen Supply strategyDuring 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%. | Procedure or surgery | the Oxygen Supply strategy |
| Emergency Medical Service intervention : Continuous Positive Airway Pressure strategyDuring 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%. | Procedure or surgery | the Continuous Positive Airway Pressure strategy |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emergency Medical Service intervention : Oxygen Supply strategy and Emergency Medical Service intervention : Continuous Positive Airway Pressure strategy in people with Drowning, run by Assistance Publique Hopitaux De Marseille at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pierre Michelet, MD (638741313 ext. +33, pierre.michelet@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inability to improve oxygen saturation up than 92% (time frame: 6 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.