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

Official title

Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial

Overview

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.

Interventions

• Drug HFNO weaning protocol
  Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done
• Drug HFNO Standard of care
  Weaning methods will be left to the free choice of the practitioner.

Primary outcome measures

• The success rate at Day 7 [Time frame: At day 7]

Secondary outcome measures (11)

• High-flow nasal oxygen therapy (HFNO) weaning rate at day 28 [Time frame: At day 28]
• Time to definitive weaning from HFNO [Time frame: From randomisation to day 28]
• Cumulative incidence of intubation [Time frame: From randomisation to day 28]
• Cumulative incidence of use of curative non-invasive ventilation [Time frame: From randomisation to day 28]
• Mortality rate at day 28 [Time frame: At Day 28]
• Number of days on HFNO for patients definitively weaned from HFNO [Time frame: From randomisation to discharge from intensive care or at Day 28]
• Changes in the ROX index during the weaning phase [Time frame: From randomisation to day 28]
• Changes in the use of accessory respiratory muscles [Time frame: From randomisation to discharge from intensive care or to Day 28]
• Progression of dyspnoea [Time frame: From randomisation to discharge from intensive care or to Day 28]
• Intensive care unit and/or continuous monitoring unit length of stay [Time frame: From randomization until the date of discharge, assessed up to 28 days maximum]
• Intensive care unit and/or continuous monitoring unit length of stay or time to ICU discharge readiness [Time frame: From randomization until the date of discharge OR ability to be discharged from intensive care, assessed up to 28 days maximum]

Eligibility criteria

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 HDNO for at least 24 hours in an intensive care unit or continuous care unit
• Treated with HFNO with a flow rate ≥ 50L/min and inspired oxygen fraction (FiO2) ≥ 0.5, at inclusion
• With a 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).
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

France · 11 centers

• Intensive care, University Hospital, Blois — Blois
• Intensive care unit, University Hospital, Bourg-en-Bresse — Bourg-en-Bresse
• Intensive care, University Hospital, Bourges — Bourges
• Intensive care unit, University Hospital, Caen — Caen
• Intensive care, University Hospital, Chartres — Chartres
• Intensive care, University Hospital, Cholet — Cholet
• Intensive care, University Hospital, Dax — Dax
• Intensive care, University Hospital, Le Mans, — Le Mans
• … and 3 more centers

Identifiers

NCT: NCT06104956 · DR230001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗