Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.

NCT07189338 · tracked via the Priya Life Science France tracker

Sponsor

University Hospital, Tours

Phase

Not applicable

Started

2025-10-30

Last updated

2025-09-23

Condition(s) studied

Hypoxemic Acute Respiratory Failure

Investigational drug(s) / intervention(s)

Apneic oxygenationUsual Care

Apneic oxygenation: * Preoxygenation will be performed using NIV for 3-5 min With nasal cannulas placed in standby beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) * Rapide sequence induction * Hypoventilation phase will be continue for 1 min using NIV * At the time of laryngoscopy : After removing the facemask, the nasal cannulas of HFNO will be placed in the patient's nares then the laryngoscopy will be performed. \* Use of capnography to confirm the success of procedure

Usual Care: * Preoxygenation will be performed using NIV for 3-5 min without HFNO * Rapide sequence induction * Hypoventilation phase will be continue using NIV for 1min * At the time of laryngoscopy : After removing the facemask, laryngoscopy will be performed without oxygen. \* Use of capnography to confirm the success of procedure

Study summary

The aim of this clinical study is to assess whether apneic oxygenation with High-Flow Nasal Oxygen (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.

The sponsor expects that apneic oxygenation (between the laryngoscopy and the success of intubation) with HFNO compared to no apneic oxygenation could decrease the risk of severe hypoxemia after intubation in hypoxemic critical ill patients.

Participants will be enrolled according to eligibility criteria and randomized into one of the following groups:

Experimental group : Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention).

non-invasive ventilation (NIV) alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy. The nasal cannulas of HFNO will be placed on hold beneath the patient's chin (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0) pending laryngoscopy began.

At the time of laryngoscopy: after removing the facemask of NIV, the nasal cannulas for HFNO will be placed in the patient's nares then the laryngoscopy will be performed.

Control group: The control group will receive usual care, i.e., no oxygen during the apneic phase (between the laryngoscopy and the success of the intubation procedure) During the preoxygenation and hypoventilation phase until laryngoscopy, NIV alone will be used as in the experimental group.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Patient admitted in the ICU * Indication of orotracheal intubation for 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) (Coudroy, Thorax 2020) * Informed consent from the patient or relatives. An emergency procedure will be possible when necessary. Exclusion Criteria: * \< 18 years old * Need for emergent intubation (i.e. cardiac arrest) * Contraindication to non-invasive ventilation for preoxygenation * Known allergy or contraindication to one of the induction drugs * SpO2 device specific for the study not available * Patients without any healthcare insurance scheme or not benefiting from it through a third party, * Persons under law protection, namely minors, pregnant or breastfeeding women, persons deprived of their liberty by a judicial or administrative decision * Previous participation in the study

Primary outcome measure(s)

Incidence of severe hypoxemia — from the start of laryngoscopy to 5 minutes after successful intubation
The incidence of severe hypoxemia defined as the occurrence of at least one episode of oxygen saturation measured by pulse oximetry (SpO2) \< 80%

Trial sites (1)

Facility	City	Region	Status
CHRU de Tours	Tours	France

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07189338 on ClinicalTrials.gov ↗ ← All trials in France