Health TrialsbyHealthPanel

Drowning-related Acute Respiratory Failure

ConditionDrowning
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1+
SponsorAssistance Publique Hopitaux De Marseille

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

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%;

Disqualifiers

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 ;

Trial design

Design model

Crossover

Treatments tested in this trial

  • Emergency Medical Service intervention : Oxygen Supply strategy

    Procedure/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 strategy

    Procedure/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%.

Treatment groups

210 Participants
are divided into 2 treatment groups
Group A: the Oxygen Supply strategyActive comparator 1 intervention
Group B: the Continuous Positive Airway Pressure strategyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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;

Time frame
6 hours
2

Glasgow Coma Scale

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

Time frame
6 hours
3

Cardiac arrest occurrence

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

Time frame
6 hours
4

Systolic arterial pressure

Indication of intubation/mechanical ventilation requirement in the first 6 hours based on following criteria : Systolic arterial pressure \< 90 mmHg

Time frame
6 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique Hopitaux De Marseille

Lead sponsor

Source ClinicalTrials.gov
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