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Weaning protocol for high-flow nasal oxygen therapy in the ICU - Multicenter randomized controlled trial. HiFloWEAN
EU CTIS ID: 2023-504366-36-00
What this study is testing
To show that the use of a protocol for weaning patients from High-Flow Nasal Oxygen Therapy increases the probability that patients will be weaned from High-Flow Nasal Oxygen Therapy at D7 post-randomization.
- 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
- Major patient (≥18 years old) admitted to the ICU or intensive care unit for acute hypoxemic respiratory failure de novo (with a PaO2/FiO2 ratio <300 mmHg).
- Treated with high-flow nasal oxygen therapy with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion
- With ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88 (the patient must not be in a worsening phase).
- Having had a gas measurement under high-flow nasal oxygen therapy within 24 hours of inclusion
- Patient affiliated to a social security scheme
- Written consent signed by the patient (by the designated person of trust, a parent, or a close relative in case the patient is incapacitated; this consent must subsequently be confirmed by the patient as soon as they are able to do so)
You likely can't join if
- Presence of a patient included in the study and not weaned from high-flow nasal oxygen therapy in the area cared for by the patient's nurse assessed for eligibility
- Patients with long-term bi-level non-invasive ventilation
- Patients on long-term home oxygen therapy
- Pregnant woman, parturient mother, and breast-feeding mother
- Patient with a medical decision not to intubate
- Patients already included in the study, neither on the same hospitalization if they were to meet the inclusion criteria again, nor on subsequent hospitalizations.
See the full eligibility criteria
- Major patient (≥18 years old) admitted to the ICU or intensive care unit for acute hypoxemic respiratory failure de novo (with a PaO2/FiO2 ratio <300 mmHg).
- Treated with high-flow nasal oxygen therapy with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion
- With ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88 (the patient must not be in a worsening phase).
- Having had a gas measurement under high-flow nasal oxygen therapy within 24 hours of inclusion
- Patient affiliated to a social security scheme
- Written consent signed by the patient (by the designated person of trust, a parent, or a close relative in case the patient is incapacitated; this consent must subsequently be confirmed by the patient as soon as they are able to do so)
- Treated with high-flow nasal oxygen in an intensive care unit or continuous care unit
- Presence of a patient included in the study and not weaned from high-flow nasal oxygen therapy in the area cared for by the patient's nurse assessed for eligibility
- Patients with long-term bi-level non-invasive ventilation
- Patients on long-term home oxygen therapy
- Pregnant woman, parturient mother, and breast-feeding mother
- Patient with a medical decision not to intubate
- Patients already included in the study, neither on the same hospitalization if they were to meet the inclusion criteria again, nor on subsequent hospitalizations.
- Individual deprived of liberty by a judicial or administrative decision, person hospitalized without consent, and person admitted to a healthcare or social facility for purposes other than research
- Minor
- Adult person subject to a legal protection measure (guardianship, curatorship, person under judicial protection)
- Concomitant non-invasive ventilation treatment (if non-invasive ventilation is weaned for at least 12 hours and high-flow nasal oxygen therapy is still in progress, the patient will be eligible for inclusion)
- Use of high-flow nasal oxygen therapy within 7 days of extubation
- Chronic obstructive pulmonary disease (Gold grade 3 or 4)
- Acute cardiogenic pulmonary edema as the primary cause of acute respiratory failure.
- Diffuse interstitial lung disease as a medical history
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.
Explore other conditions
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.