Authorised Therapeutic confirmatory (Phase III) Hypoxemic acute respiratory failure

Apneic oxygenation with high-flow nasal oxygenation after preoxygenation with noninvasive ventilation before intubation in hypoxemic patients in intensive care unit. A multicenter randomized controlled trial.

EU CTIS ID: 2024-514949-11-00

What this study is testing

To assess whether apneic oxygenation with 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.

  • Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • Patient admitted in the ICU
  • Indication of orotracheal intubation
  • 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)
  • Informed consent from the patient or relatives. An emergency procedure will be possible when necessary.

You likely can't join 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
See the full eligibility criteria
Who can join
  • Patient admitted in the ICU
  • Indication of orotracheal intubation
  • 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)
  • Informed consent from the patient or relatives. An emergency procedure will be possible when necessary.
What rules you out
  • < 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

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.