Respiratory Failure With HypoxiaHFNO-WeaningNCT07030413
Weaning From High Flow Nasal Oxygen in Acute Respiratory Failure : a Target Trial Emulation
An observational study of Respiratory Failure With Hypoxia and Respiratory Failure, ICU, run by Poitiers University Hospital at 3 sites in France.
Trial summary
Acute respiratory failure is a frequent reason for admission to the intensive care unit (ICU). It is associated with high healthcare consumption and mortality. High-flow nasal oxygen (HFNO) improves comfort, reduces the risk of intubation and may reduce the risk of mortality in the most severe patients with acute… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure With Hypoxia, Respiratory Failure, ICU, High-Flow Nasal Oxygen Therapy
- How many people
- 2,000 participants
- Where
- 3 sitesFrance
- Study dates
- 1 Nov 2019to 31 Dec 2025
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All ICU patients admitted to the 3 participating centers and treated with HFNO at the attending physician's discretion for acute respiratory failure.
Who may be able to join
- Adult patients (age > 18)
- Admitted to participating ICUs
- Treated with HFNO at the attending physician's discretion for acute respiratory failure (defined as respiratory rate ≥ 25 breaths/min)
Who cannot join
- Prophylactic HFNO to prevent reintubation after extubation
- Noninvasive ventilation before HFNO initiation
Trial locations and contacts
3 sites in 1 country.
France3 sites
University Hospital Bordeaux
Bordeaux, 33400
University Hospital Limoges
Limoges
University Hospital Poitiers
Poitiers, 86000
About this study
Official title: Weaning From High Flow Nasal Oxygen in Acute Respiratory Failure : a Target Trial Emulation From Nouvelle-Aquitaine Health Data Warehouses
Acute respiratory failure is a frequent reason for admission to the intensive care unit (ICU). It is associated with high healthcare consumption and mortality.
High-flow nasal oxygen (HFNO) improves comfort, reduces the risk of intubation and may reduce the risk of mortality in the most severe patients with acute hypoxemic respiratory failure compared with other oxygenation strategies. Therefore, HFNO is recommended as a first-line non-invasive oxygenation strategy in acute hypoxemic respiratory failure.
Read more
The timing of weaning patients from HFNO is complex. On the one hand, failure to wean from HFNO is associated with prolonged duration of HFNO and prolonged ICU stay. On the other hand, continued HFNO in patients ready to be weaned may unnecessarily prolong ICU stay and contribute to overwhelming of ICU capacities.
The overarching goal of this study is to identify the characteristics of patients in whom weaning from HFNO is not beneficial.
- Conditions
- Respiratory Failure With Hypoxia, Respiratory Failure, ICU, High-Flow Nasal Oxygen Therapy
- Keywords
- high-flow nasal oxygen therapy, acute hypoxemic respiratory failure, weaning
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HFNO weaning trial group | Patients who underwent at least one weaning trial from HFNO | |
| No HFNO weaning trial group | Patients who did not underwent HFNO weaning trial |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-free days at day 90
The number of days alive out of hospital between pseudorandomization and D90. For patients who died, the hospital-free days at day 90 will be equal to 0.
Measured: 90 days
Secondary outcomes (3)
Duration of intensive care unit (ICU) stay
The number of days spent in the ICU
Measured: 90 days
ICU mortality
The number (and proportion) of patients who died in the ICU
Measured: 90 days
Survival at day 90
The number (and proportion) of patients alive at day 90 from pseudorandomization
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start1 Nov 2019
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Respiratory Failure With HypoxiaStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Limoges
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030413
- Sponsor's protocol ID
- HFNO-Weaning
- Acronym
- HFNO-Weaning
- Status last verified
- Aug 2025
- First submitted
- 12 Jun 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be made available after reasonable request and it has been discussed among the steering committee.
Publications
Rodriguez M, Thille AW, Boissier F, Veinstein A, Chatellier D, Robert R, Le Pape S, Frat JP, Coudroy R. Predictors of successful separation from high-flow nasal oxygen therapy in patients with acute respiratory failure: a retrospective monocenter study. Ann Intensive Care. 2019 Sep 11;9(1):101. doi: 10.1186/s13613-019-0578-8.
PubMed 31511996Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
PubMed 34649974
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weaning From High Flow Nasal Oxygen in Acute Respiratory Failure : a Target Trial Emulation From Nouvelle-Aquitaine Health Data Warehouses
- ClinicalTrials.gov ID
- NCT07030413
- Acronym / sponsor ID
- HFNO-Weaning / HFNO-Weaning
- Conditions
- Respiratory Failure With Hypoxia, Respiratory Failure, ICU, High-Flow Nasal Oxygen Therapy
- Keywords
- high-flow nasal oxygen therapy, acute hypoxemic respiratory failure, weaning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux, University Hospital, Limoges
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 Jun 2025 (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.
Acute respiratory failure is a frequent reason for admission to the intensive care unit (ICU). It is associated with high healthcare consumption and mortality.
High-flow nasal oxygen (HFNO) improves comfort, reduces the risk of intubation and may reduce the risk of mortality in the most severe patients with acute hypoxemic respiratory failure compared with other oxygenation strategies. Therefore, HFNO is recommended as a first-line non-invasive oxygenation strategy in acute hypoxemic respiratory failure.
The timing of weaning patients from HFNO is complex. On the one hand, failure to wean from HFNO is associated with prolonged duration of HFNO and prolonged ICU stay. On the other hand, continued HFNO in patients ready to be weaned may unnecessarily prolong ICU stay and contribute to overwhelming of ICU capacities.
The overarching goal of this study is to identify the characteristics of patients in whom weaning from HFNO is not beneficial.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNO weaning trial group | – | –Patients who underwent at least one weaning trial from HFNO |
| No HFNO weaning trial group | – | –Patients who did not underwent HFNO weaning trial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All ICU patients admitted to the 3 participating centers and treated with HFNO at the attending physician's discretion for acute respiratory failure.
Key inclusion criteria (3 listed)
- Adult patients (age > 18)
- Admitted to participating ICUs
- Treated with HFNO at the attending physician's discretion for acute respiratory failure (defined as respiratory rate ≥ 25 breaths/min)
Key exclusion criteria (2 listed)
- Prophylactic HFNO to prevent reintubation after extubation
- Noninvasive ventilation before HFNO initiation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hospital-free days at day 90
Time frame: 90 days
The number of days alive out of hospital between pseudorandomization and D90. For patients who died, the hospital-free days at day 90 will be equal to 0.
3 secondary outcomes
Duration of intensive care unit (ICU) stay
Time frame: 90 days
ICU mortality
Time frame: 90 days
Survival at day 90
Time frame: 90 days
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 8 Aug 2025.
- Background: PubMed 31511996Rodriguez M, Thille AW, Boissier F, Veinstein A, Chatellier D, Robert R, Le Pape S, Frat JP, Coudroy R. Predictors of successful separation from high-flow nasal oxygen therapy in patients with acute respiratory failure: a retrospective monocenter study. Ann Intensive Care. 2019 Sep 11;9(1):101. doi: 10.1186/s13613-019-0578-8.
- Results publication: PubMed 34649974Oczkowski S, Ergan B, Bos L, Chatwin M, Ferrer M, Gregoretti C, Heunks L, Frat JP, Longhini F, Nava S, Navalesi P, Ozsancak Ugurlu A, Pisani L, Renda T, Thille AW, Winck JC, Windisch W, Tonia T, Boyd J, Sotgiu G, Scala R. ERS clinical practice guidelines: high-flow nasal cannula in acute respiratory failure. Eur Respir J. 2022 Apr 14;59(4):2101574. doi: 10.1183/13993003.01574-2021. Print 2022 Apr.
- Individual participant dataSharing planned: Undecided. Data will be made available after reasonable request and it has been discussed among the steering committee.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Failure With Hypoxia and Respiratory Failure, ICU, run by Poitiers University Hospital at 3 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital-free days at day 90 (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07030413, which also lists 2 linked publications.
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 8 Aug 2025.