Weaning protocol for high-flow nasal oxygen therapy in the ICU - Multicenter randomized controlled trial. HiFloWEA
- Conditions
- de novo acute respiratory failureMedDRA version: 21.0Level: LLTClassification code: 10000953Term: Acute on chronic respiratory failure Class: 10038738Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 370
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, with flow rate and FiO2 stable (i.e. not increased) in the 24 hours prior to inclusion, With ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88, 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)
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 non-invasive ventilation with external positive pressure, 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method