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Apneic oxygenation with high-flow nasal oxygenation after preoxygenation with noninvasive ventilation before intubation in hypoxemic patients in intensive care unit. A multicenter randomized controlled trial.

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514949-11-00
Acronym
DR240020
Enrollment
500
Registered
2025-08-14
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxemic acute respiratory failure

Brief summary

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)

Detailed description

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), The highest and lowest SpO2 values during the procedure (from the start of laryngoscopy to 5 minutes after successful intubation), 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)., 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., The duration of laryngoscopy and the number of laryngoscopies will be compared in both group (from the 1st attempt to the successful intubation), Vital status at day 28

Interventions

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
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), The highest and lowest SpO2 values during the procedure (from the start of laryngoscopy to 5 minutes after successful intubation), 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)., 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 fol

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026