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.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Regional Universitaire De Tours

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

18 Mar 2026 → ongoing

Decision date (initial)

2025-08-14

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

DGOS

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To assess whether apneic oxygenation with HFNO would decrease the incidence of severe hypoxemia compared to no apneic oxygenation during the intubation procedure (from the start of laryngoscopy to 5 minutes after successful intubation) in patients with hypoxemic acute respiratory failure.

Secondary objectives 6

1. To compare between the two groups: The incidence of prolonged severe hypoxemia during the procedure
2. The highest and lowest SpO2 values during the procedure
3. The incidence of immediate severe complications including cardiovascular instability (systolic arterial blood pressure <65 mm Hg 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)
4. The incidence of 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.
5. The duration of laryngoscopy and the number of laryngoscopies
6. Mortality at day 28

Conditions and MedDRA coding

Hypoxemic acute respiratory failure

Study design 1 period

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 4

1. Patient admitted in the ICU
2. Indication of orotracheal intubation
3. 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)
4. Informed consent from the patient or relatives. An emergency procedure will be possible when necessary.

Exclusion criteria 8

1. < 18 years old
2. Need for emergent intubation (i.e. cardiac arrest)
3. Contraindication to non-invasive ventilation for preoxygenation
4. Known allergy or contraindication to one of the induction drugs
5. SpO2 device specific for the study not available
6. Patients without any healthcare insurance scheme or not benefiting from it through a third party
7. Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision.
8. Previous participation in the study

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 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 endpoints 6

1. 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)
2. The highest and lowest SpO2 values during the procedure (from the start of laryngoscopy to 5 minutes after successful intubation)
3. 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).
4. 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.
5. The duration of laryngoscopy and the number of laryngoscopies will be compared in both group (from the 1st attempt to the successful intubation)
6. Vital status at day 28

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Regional Universitaire De Tours

Sponsor organisation

Centre Hospitalier Regional Universitaire De Tours

Address

2 Boulevard Tonnelle

City

Tours Cedex 9

Postcode

37044

Country

France

Scientific contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Mai-Anh NAY

Public contact point

Organisation

Centre Hospitalier Regional Universitaire De Tours

Contact name

Mai-Anh NAY

Locations

1 EU/EEA country · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 17 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications