NCT07189338 Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.
| NCT ID | NCT07189338 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Hypoxemic Acute Respiratory Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2026-03-20 |
| Primary Completion | 2029-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 500 participants in total. It began in 2026-03-20 with a primary completion date of 2029-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07189338 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypoxemic Acute Respiratory Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07189338 currently recruiting?
Yes, NCT07189338 is actively recruiting participants. Contact the research team at mainah.nay@chu-orleans.fr for enrollment information.
Where is the NCT07189338 trial being conducted?
This trial is being conducted at Tours, France.
Who is sponsoring the NCT07189338 clinical trial?
NCT07189338 is sponsored by University Hospital, Tours. The trial plans to enroll 500 participants.