Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care (HiFloWEAN)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Acute Hypoxemic Respiratory Failure; High-flow Nasal Oxygen Therapy

Treatments: Drug: HFNO weaning protocol; Drug: Standard of care

Study type: Interventional

Funder types: Other

Identifiers

NCT06104956

DR230001

Details and patient eligibility

About

High-flow nasal oxygen therapy (HFNO) is an oxygenation technique frequently used in intensive care.

The main objective of our study is to show that the use of a protocol for weaning patients off high-flow nasal oxygen therapy (HFNO) in the intensive care unit increases the probability that patients will be weaned from HFNO at Day 7 post-randomisation.

This is a open-label multicentre randomised controlled trial conducted in two parallel groups.

The primary endpoint is the success rate at Day 7, with success defined as "definitive" weaning from HFNO, i.e. patients weaned from HFNO for more than 48 hours without recourse to non-invasive ventilation (NIV) or intubation and still alive at Day 7.

The weaning protocol will be started as soon as the patient meets all the inclusion criteria, considered to be the prerequisites for initiating weaning from HFNO. Patients will be monitored until Day 28 maximum.

Enrollment: 370 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major patient admitted to the intensive care unit or continuous care unit for de novo hypoxaemic acute respiratory failure (with a PaO2/FiO2 ratio <300 mmHg)
• Treated with HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, flow rate and FiO2 having to be stable (i.e. not increased) in the 24 hours prior to inclusion
• With a ROX index (SpO2/FiO2/Respiratory Rate) stable or improving in the 6 hours prior to inclusion and greater than 4.88
• Had a blood gas test under HFNO within 24 hours of inclusion
• Participant covered by or entitled to social security
• Informed consent signed by the patient or its relatives if the patient is incapable; this consent must then be confirmed by the patient as soon as possible

Exclusion criteria

• Presence of a patient included in the study and not weaned off HFNO in the sector managed by the nurse of the patient assessed for eligibility
• Concomitant non-invasive ventilation treatment
• Use of HFNO within 7 days of extubation
• Chronic obstructive pulmonary disease (Gold grade 3 or 4)
• Cardiogenic acute pulmonary oedema as the main cause of acute respiratory failure
• Diffuse interstitial lung disease as a medical history
• Patient with long-term non-invasive ventilation with external positive pressure
• Patient on long-term oxygen therapy at home
• Pregnant women, women in labour and breastfeeding mothers
• Persons deprived of their liberty by a judicial or administrative decision, persons hospitalised without consent and persons admitted to a health or social establishment for purposes other than research.
• Minor
• Adult subject to a legal protection measure (guardianship, curators, person under court protection)
• Patient with a medical decision not to intubate
• Patients already included in the study, neither for the same stay if they were to present the inclusion criteria again, nor for subsequent stays

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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370 participants in 2 patient groups

Experimental group : Imposed weaning protocol

Experimental group

Description:

The flow of the HFNO will remain high (50-60 L/min) guaranteeing the effectiveness of the HFNO on the wash-out of the anatomical space. At the same time, weaning will begin with a gradual reduction in FiO2 of 0.1 every 4 hours. To achieve this reduction, the patient will have to meet the safety targets of a stable respiratory rate at rest (no increase) and pulsed oxygen saturation (SpO2). The SpO2 target will be 92-95%. Once the FiO2 has stabilised at 0.4 for 4 hours, the nurse will initiate a 10 L/min reduction in the flow of HFNO every 4 hours. The oxygen therapy support may be changed for standard oxygen when the HFNO flow rate is 40L/min with an FIO2 of 0.4 for 4 consecutive hours.

Treatment:

Drug: HFNO weaning protocol

Control group

Active Comparator group

Description:

Weaning methods will be left to the free choice of the practitioner. Any change in the HFNO setting must be made on medical prescription. A minimum SpO2 objective is required (SpO2 ≥92%).

Treatment:

Drug: Standard of care