Apneic oxygenation with high-flow nasal oxygen during intubation in hypoxemic ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study compares apneic oxygenation with high-flow nasal oxygen (HFNO) to usual care during intubation in adults with hypoxemic acute respiratory failure in the ICU. Eligible participants will be randomized to receive HFNO-apneic oxygenation between laryngoscopy and the moment of successful intubation, or to preoxygenation with non-invasive ventilation without HFNO during the procedure. Outcomes focus on the incidence of severe hypoxemia surrounding intubation, with attention to safety during the apnea and hypoventilation phases. The trial aims to determine if HFNO-apneic oxygenation can reduce hypoxemic events and potentially improve stability during airway management in this high-risk population. Prior data suggest potential benefit of apneic oxygenation in emergency settings, but evidence in hypoxemic ICU patients remains to be clarified.

Why it matters

Who can join: the full rules

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

Where it's running

• CHRU de Tours
  Tours, France Recruiting

Study contacts

• Study coordinator: Mai-Anh Nay, MD
• Email: mainah.nay@chu-orleans.fr
• Phone: +33 2 38 57 52 53

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Predicting HFNC Failure in Acute Hypoxemic Respiratory Failure using Metabolomics and Clinical Data

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.