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

Acute Hypoxemic Respiratory Failure Clinical Trial

— HiFloWEAN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06104956
• Other study ID #: DR230001
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2024
• Est. completion date: March 2027

Study information

• Verified date: February 2024
• Source: University Hospital, Tours
• Contact: Mai-Anh NAY, MD
• Phone: 02.38.51.44.46
• Email: mai-anh.nay[@]chr-orleans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: March 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Hypoxemic Respiratory Failure
• High-flow Nasal Oxygen Therapy
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
France	Intensive care, University Hospital, Blois	Blois
France	Intensive care unit, University Hospital, Bourg-en-Bresse	Bourg-en-Bresse
France	Intensive care, University Hospital, Bourges	Bourges
France	Intensive care, University Hospital, Chartres	Chartres
France	Intensive care, University Hospital, Cholet	Cholet
France	Intensive care, University Hospital, Dax	Dax
France	Intensive care, University Hospital, Le Mans,	Le Mans
France	Intensive care, University Hospital, Orléans	Orléans
France	Intensive care, University Hospital, Tours	Tours
France	Intensive care unit, University Hospital, Vannes	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The success rate at Day 7	Success being defined as "definitive" weaning from HFNO, i.e. a patient weaned for more than 48 hours from HFNO without recourse to non-invasive ventilation or intubation and still alive at Day 7.	At day 7
Secondary	High-flow nasal oxygen therapy (HFNO) weaning rate at day 28		At day 28
Secondary	Time to definitive weaning from HFNO		From randomisation to day 28
Secondary	Cumulative incidence of intubation		From randomisation to day 28
Secondary	Cumulative incidence of use of curative non-invasive ventilation		From randomisation to day 28
Secondary	Mortality rate at day 28		At Day 28
Secondary	Number of days on HFNO for patients definitively weaned from HFNO		From randomisation to discharge from intensive care or at Day 28
Secondary	Changes in the ROX index during the weaning phase	ROX index : [(SpO2/FiO2)/respiratory rate]	From randomisation to day 28
Secondary	Changes in the use of accessory respiratory muscles	Using the Patrick score (Score from 0 to 5)	From randomisation to discharge from intensive care or to Day 28
Secondary	Progression of dyspnoea	Assessed by the modified Borg scale (scale from 0 to 10)	From randomisation to discharge from intensive care or to Day 28
Secondary	Intensive care unit and/or continuous monitoring unit length of stay		From randomization until the date of discharge, assessed up to 28 days maximum
Secondary	Intensive care unit and/or continuous monitoring unit length of stay or time to ICU discharge readiness	The ability to go out will be defined by the validation of all the items on the modified ability grid (score modified from Hiller et al. ; 28 items)	From randomization until the date of discharge OR ability to be discharged from intensive care, assessed up to 28 days maximum