Status:
NOT_YET_RECRUITING
Apneic Oxygenation With High-flow Nasal Oxygenation After Preoxygenation With Noninvasive Ventilation Before Intubation in Hypoxemic Patients in Intensive Care Unit.
Lead Sponsor:
University Hospital, Tours
Conditions:
Hypoxemic Acute Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
Detailed Description
Endotracheal intubation is often performed in intensive care unit (ICU). Severe complications (such as severe hypoxemia, hypotension, cardiac arrest) occur up to 50%. Severe hypoxemia is more frequent...
Eligibility Criteria
Inclusion
- 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
- \< 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
Key Trial Info
Start Date :
October 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2028
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT07189338
Start Date
October 30 2025
End Date
November 30 2028
Last Update
September 23 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHRU de Tours
Tours, France, 37000