Oxygen for Hypoxemic acute respiratory failure

Inclusion criteria

• {"criterion_text":"- Patient admitted in the ICU\n- Indication of orotracheal intubation\n- Hypoxemic acute respiratory failure defined by: ○ One sign of acute respiratory distress (respiratory rate >25/min, dyspnea or the use of accessory respiratory muscle) ○ AND a PaO2/FiO2 ≤ 200 mmHg (measured or calculated FiO2) within 6 hours before the decision of intubation. For the calculation of FiO2, the FiO2 will be estimated by: FiO2 = 0.21 + 0.03 x (flow of oxygen)\n- Informed consent from the patient or relatives. An emergency procedure will be possible when necessary."}

Exclusion criteria

• {"criterion_text":"- < 18 years old\n- Need for emergent intubation (i.e. cardiac arrest)\n- Contraindication to non-invasive ventilation for preoxygenation\n- Known allergy or contraindication to one of the induction drugs\n- SpO2 device specific for the study not available\n- Patients without any healthcare insurance scheme or not benefiting from it through a third party\n- Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.\n- Previous participation in the study"}

Primary endpoints

• {"endpoint_text":"- The incidence of severe hypoxemia defined as the occurrence of at least one episode of oxygen saturation measured by pulse oximetry (SpO2) < 80% (from the start of laryngoscopy to 5 minutes after successful intubation)","definition_or_measurement_approach":"Oxygen saturation measured by pulse oximetry (SpO2); severe hypoxemia defined as SpO2 < 80% measured from the start of laryngoscopy to 5 minutes after successful intubation."}

Secondary endpoints

• {"endpoint_text":"- The incidence of prolonged severe hypoxemia defined by an SpO2 < 80% for more than 24 seconds (from the start of laryngoscopy to 5 minutes after successful intubation)","definition_or_measurement_approach":"Prolonged severe hypoxemia defined as SpO2 < 80% for more than 24 seconds during the period from start of laryngoscopy to 5 minutes after successful intubation."}
• {"endpoint_text":"- The highest and lowest SpO2 values during the procedure (from the start of laryngoscopy to 5 minutes after successful intubation)","definition_or_measurement_approach":"Maximum and minimum SpO2 measured by pulse oximetry during the procedure window (start of laryngoscopy to 5 minutes post-intubation)."}
• {"endpoint_text":"- The occurrence of each immediate severe complications (from the start of laryngoscopy to 5 minutes after successful intubation) including cardiovascular instability (systolic arterial blood pressure <65 mmHg at least once, new or increase need of vasopressors or fluid bolus >15 mL/kg), cardiac arrest, new onset cardiac arrhythmia (atrial fibrillation, ventricular tachycardia, bradycardia <30beats per minute).","definition_or_measurement_approach":"Immediate severe complications recorded during the procedure window; includes specified cardiovascular instability thresholds, cardiac arrest, and new arrhythmias as defined."}
• {"endpoint_text":"- The occurrence of each other adverse events: difficult intubation (defined as a procedure requiring more than 2 laryngoscopy attempts before success), operator-reported aspiration between induction and intubation, dental injury, esophageal intubation, pneumothorax visualized on the follow-up chest X-ray as part of the patient's routine care.","definition_or_measurement_approach":"Adverse events recorded as specified; difficult intubation defined as >2 laryngoscopy attempts; pneumothorax confirmed by routine follow-up chest X-ray."}
• {"endpoint_text":"- The duration of laryngoscopy and the number of laryngoscopies will be compared in both group (from the 1st attempt to the successful intubation)","definition_or_measurement_approach":"Measured duration from first laryngoscopy attempt to successful intubation and count of laryngoscopy attempts."}
• {"endpoint_text":"- Vital status at day 28","definition_or_measurement_approach":"Vital status assessed at day 28 post-procedure."}

France

Earliest CTIS Part Ii Submission Date

26-06-2025

Latest Decision Or Authorization Date

14-08-2025

Processing Time Days

49

Number Of Sites

14

Number Of Participants

500

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France

Third parties

• {"country":"","full_name":"DGOS","duties_or_roles":"Source of monetary support","organisation_type":""}