Drowning-related Acute Respiratory Failure

Condition(s) studied

Investigational drug(s) / intervention(s)

Emergency Medical Service intervention : Oxygen Supply strategy: 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: 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 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).

Eligibility

Primary outcome measure(s)

• 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 sites (9)

More Assistance Publique Hopitaux De Marseille trials in France