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

NCT07189338 | Not Yet Recruiting

• 1 other identifier: DR240020
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypoxemic Acute Respiratory Failure

Keywords

IUC; Hypoxemic acute respiratory failure; HFNO

Outcome Measures

Primary Outcomes (1)

• Incidence of severe hypoxemia

  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 Outcomes (7)

• Incidence of prolonged severe hypoxemia

  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

• The occurrence of each other adverse events

  from the start of laryngoscopy to 5 minutes after successful intubation; At Day 28

• Duration of laryngoscopy

  From the 1st attempt to the successful intubation

Study Arms (2)

Experimental group

EXPERIMENTAL

Apneic oxygenation will be used with HFNO between the laryngoscopy and the successful intubation (study intervention). NIV alone will be used for the preoxygenation and hypoventilation phase until the laryngoscopy. Apneic oxygenation will be used with HFNO at the time of laryngoscopy after removing the facemask of NIV (with HFNO on and set with a flow at 60-70L.min-1, FiO2 1.0)

Procedure: Apneic oxygenation

Control group

OTHER

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.

Procedure: Usual Care

Interventions

Apneic oxygenation PROCEDURE

* 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

Experimental group

Usual Care PROCEDURE

* 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

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

CHRU de Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Mai-Anh Nay, MD

CONTACT

+33 2 38 57 52 53; mainah.nay@chu-orleans.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 23, 2025
• Study Start: October 30, 2025
• Primary Completion (Estimated): October 30, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

FR (1)