Acute Hypoxemic Respiratory FailureHiFloWEANNCT06104956
Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care
A study testing HFNO weaning protocol in people with Acute Hypoxemic Respiratory Failure and High-flow Nasal Oxygen Therapy, run by University Hospital, Tours at 11 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Hypoxemic Respiratory Failure, High-flow Nasal Oxygen Therapy
- What is being tested?
- HFNO weaning protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 11 sitesFrance
- Study dates
- 17 Feb 2024to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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 locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
Intensive care, University Hospital, Blois
Blois
Julien GROUILLE, MD
Julien GROUILLE
- Recruiting
Intensive care unit, University Hospital, Bourg-en-Bresse
Bourg-en-Bresse
Salman Mohammad
Salman MOHAMMAD
- Recruiting
Intensive care, University Hospital, Bourges
Bourges
Anna BOURREAU, MD
Anna BOURREAU
- Not yet recruiting
Intensive care unit, University Hospital, Caen
Caen
Pierrick BAUDUIN, 0662885851, bauduin-p@chu-caen.fr
Pierrick BAUDUIN
- Recruiting
Intensive care, University Hospital, Chartres
Chartres
Juliette AUDIBERT, MD
Juliette AUDIBERT
- Recruiting
Intensive care, University Hospital, Cholet
Cholet
Fabien JAROUSSEAU, MD
Fabien JAROUSSEAU
- Recruiting
Intensive care, University Hospital, Dax
Dax
Adrien AUVET, MD
Adrien AUVET
- Recruiting
Intensive care, University Hospital, Le Mans,
Le Mans
Mickael LANDAIS, MD
Mickael LANDAIS
- Recruiting
Intensive care, University Hospital, Orléans
Orléans
Mai-Anh NAY, MD
Mai-Anh NAY
- Recruiting
Intensive care, University Hospital, Tours
Tours
Sophie JACQUIER, MD
Sophie JACQUIER
- Recruiting
Intensive care unit, University Hospital, Vannes
Vannes
Agathe DELBOVE, MD
Agathe DELBOVE
About this study
Official title: Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial
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.
Read more
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.
- Being tested
- HFNO weaning protocol, HFNO Standard of care
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNO weaning protocolDrug
Algorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done
HFNO Standard of careDrug
Weaning methods will be left to the free choice of the practitioner.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group : Imposed weaning protocol | Experimental | 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. Receives: Drug: HFNO weaning protocol |
| Control group | Active comparator | 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%). Receives: Drug: HFNO Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At day 7
Secondary outcomes (11)
High-flow nasal oxygen therapy (HFNO) weaning rate at day 28
Measured: At day 28
Time to definitive weaning from HFNO
Measured: From randomisation to day 28
Cumulative incidence of intubation
Measured: From randomisation to day 28
Cumulative incidence of use of curative non-invasive ventilation
Measured: From randomisation to day 28
Mortality rate at day 28
Measured: At Day 28
Number of days on HFNO for patients definitively weaned from HFNO
Measured: From randomisation to discharge from intensive care or at Day 28
Changes in the ROX index during the weaning phase
ROX index : [(SpO2/FiO2)/respiratory rate]
Measured: From randomisation to day 28
Changes in the use of accessory respiratory muscles
Using the Patrick score (Score from 0 to 5)
Measured: From randomisation to discharge from intensive care or to Day 28
Progression of dyspnoea
Assessed by the modified Borg scale (scale from 0 to 10)
Measured: From randomisation to discharge from intensive care or to Day 28
Intensive care unit and/or continuous monitoring unit length of stay
Measured: 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
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)
Measured: From randomization until the date of discharge OR ability to be discharged from intensive care, assessed up to 28 days maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start17 Feb 2024
- Primary completionFeb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Hypoxemic Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mai-Anh NAY, MD, Principal investigator, CHRU Orléans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06104956
- Sponsor's protocol ID
- DR230001
- Acronym
- HiFloWEAN
- Status last verified
- Jul 2025
- First submitted
- 12 Oct 2023
- Last updated
- 30 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning Protocol for High-flow Nasal Oxygen Therapy in Intensive Care: A Multicentre Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06104956
- Acronym / sponsor ID
- HiFloWEAN / DR230001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group : Imposed weaning protocol | Experimental | Drug: HFNO weaning protocolThe 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. |
| Control group | Active comparator | Drug: HFNO Standard of careWeaning 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%). |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HFNO weaning protocolAlgorithm based on SpO2 values and respiratory rate: a decrease of FiO2 and of the flow will be done | Drug | Experimental group : Imposed weaning protocol |
| HFNO Standard of careWeaning methods will be left to the free choice of the practitioner. | Drug | Control group |
Primary outcome
The success rate at Day 7
Time frame: 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.
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mai-Anh NAY, MD principal investigator
CHRU Orléans
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNO weaning protocol in people with Acute Hypoxemic Respiratory Failure and High-flow Nasal Oxygen Therapy, run by University Hospital, Tours at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mai-Anh NAY, MD (02.38.51.44.46 ext. +33, mai-anh.nay@chr-orleans.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The success rate at Day 7 (time frame: At day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2025.