Respiratory FailureHONIVAHNCT05643911
Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway
A study testing HFNC and NIV in people with Respiratory Failure, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- HFNC and NIV
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 27 Jan 2023to Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95%
- Adult (age ≥ 18 years)
- (2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study.
Who cannot join
- NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure < 90 mmHg or mean blood pressure < 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less)
- History of recent facial trauma not compatible with the use of nasal cannulas
- Pregnancy
- Refusal of study participation
- protected person
- Patient not affiliated to the social security system or not benefiting from such a system
- Lack of signed informed consent
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Universitaire Montpellier, Saint Eloi
Montpellier, Languedoc-Roussillon, 34295
Samir JABER, MD, PhD, +33467337271, s-jaber@chu-montpellier.fr
Samir JABER, MD, PhD
About this study
Official title: Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway in Hypoxemic Critical Care Patients: a Physiological Randomized Controlled Trial
Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Symptomatic treatment of hypoxemic respiratory failure is a controversial topic with different options: 1) standard oxygen therapy, 2) high flow nasal cannula oxygen therapy (HFNC) and 3) non-invasive ventilation (NIV).
The aim of the study is to compare HFNC versus NIV ventilation using CT scan. The hypothesis of this study is that in hypoxemic critically ill patients, the increase of lung volumes with NIV would be significantly higher than the increase of lung volumes with HFNC.
- Conditions
- Respiratory Failure
- Being tested
- HFNC, NIV
- Keywords
- intensive care, non-invasive ventilation, high-flow nasal oxygen therapy, hypoxemic respiratory failure, upper airway
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HFNCProcedure or surgery
In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes.
NIVProcedure or surgery
Patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance.
| Study group | Role | What they receive |
|---|---|---|
| HFNC (Hight-flow oxygen therapy) | Experimental | In the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes. Oxygen will be passed through a heated humidifier and continuously delivered through medium or large nasal cannulas (OptiflowTM, Fisher and Paykel Healthcare) depending on patient anatomy, with a gas flow of 50 litres per minute and the FiO2 will be adjusted to maintain a SpO2 between 95% and 98%. Receives: Procedure: HFNC |
| Non-invasive ventilation (NIV) | Active comparator | In the NIV Group, patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance. The pressure-support level will be adjusted with the aim of an expired tidal volume of 6 to 8 ml per kilogram of predicted body weight, with a positive end-expiratory pressure (PEEP) of 5 cmH2O. The FiO2 will be adjusted to maintain a SpO2 between 95% and 98%. Receives: Procedure: NIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in poorly aerated lung volume
The poorly aerated volume will be measured by CT scan
Measured: the day of inclusion
Variation in non-aereted lung volume
The non-aereted volume will be measured by CT scan
Measured: the day of inclusion
Secondary outcomes (9)
Variation in cross-sectional upper airway area
The variation will be measured by CT-scan in mm
Measured: the day of inclusion
Variation in normally aerated lung volume
The normally aerated lung volume will be measured by CT scan
Measured: the day of inclusion
Variation in Positive End Expiratory Pressure (PEEP)
Measured: the day of inclusion
Variation in Total lung volume
The total lung volume will be measured by CT-scan
Measured: the day of inclusion
Variation in O2 gas exchange
Change in PaO2 in mmHg
Measured: the day of inclusion
Variation in CO2 gas exchange
Change in PaO2 in mmHg
Measured: the day of inclusion
Variation in respiratory rate
Respiratory rate is the number of cycles per minute
Measured: the day of inclusion
Variation in cardiac output (Qc)
the cardiac output is in L/min
Measured: the day of inclusion
Variation in patient comfort
Patient comfort through a numeric rating scale (NRS) from 0 (no discomfort) to 10 (maximum imaginable discomfort)
Measured: the day of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start27 Jan 2023
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643911
- Sponsor's protocol ID
- RECHMPL22_0510
- Acronym
- HONIVAH
- Status last verified
- May 2024
- First submitted
- 17 Nov 2022
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Monet C, Piron L, Pressac M, Molinari N, De Jong A, Guiu B, Jaber S. Study protocol for the HONIVAH trial: a single-centre randomised study assessing high-flow oxygen therapy versus non-invasive ventilation on lung volumes and the upper airway in hypoxemic critically ill patients. BMJ Open. 2025 Sep 16;15(9):e106340. doi: 10.1136/bmjopen-2025-106340.
PubMed 40962342
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of High-flow Oxygen Therapy and Non-invasive Ventilation on Lung Volumes and on Upper Airway in Hypoxemic Critical Care Patients: a Physiological Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05643911
- Acronym / sponsor ID
- HONIVAH / RECHMPL22_0510
- Conditions
- Respiratory Failure
- Keywords
- intensive care, non-invasive ventilation, high-flow nasal oxygen therapy, hypoxemic respiratory failure, upper airway
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 27 Jan 2023 (actual)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 9 Dec 2022 (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.
Respiratory failure is the most frequent organ failure and cause for admission in the Intensive Care Unit (ICU) . It is a severe complication with an ICU mortality ranged from 31% to 33%. Symptomatic treatment of hypoxemic respiratory failure is a controversial topic with different options: 1) standard oxygen therapy, 2) high flow nasal cannula oxygen therapy (HFNC) and 3) non-invasive ventilation (NIV).
The aim of the study is to compare HFNC versus NIV ventilation using CT scan. The hypothesis of this study is that in hypoxemic critically ill patients, the increase of lung volumes with NIV would be significantly higher than the increase of lung volumes with HFNC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC (Hight-flow oxygen therapy) | Experimental | Procedure: HFNCIn the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes. Oxygen will be passed through a heated humidifier and continuously delivered through medium or large nasal cannulas (OptiflowTM, Fisher and Paykel Healthcare) depending on patient anatomy, with a gas flow of 50 litres per minute and the FiO2 will be adjusted to maintain a SpO2 between 95% and 98%. |
| Non-invasive ventilation (NIV) | Active comparator | Procedure: NIVIn the NIV Group, patients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance. The pressure-support level will be adjusted with the aim of an expired tidal volume of 6 to 8 ml per kilogram of predicted body weight, with a positive end-expiratory pressure (PEEP) of 5 cmH2O. The FiO2 will be adjusted to maintain a SpO2 between 95% and 98%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient with hypoxemia at any time of ICU stay defined as follow: standard oxygen therapy flow ≥ 3L/min to maintain a pulsed oxygen saturation ≥ 95%
- Adult (age ≥ 18 years)
- (2) A CT scan prescribed by the physician in charge of the patient as part of the exploration of the patient's pathology and not as part of a "dedicated" prescription for the study.
Key exclusion criteria (7 listed)
- NIV contraindication (need for immediate endotracheal intubation and mechanical ventilation; hemodynamic instability defined by systolic blood pressure < 90 mmHg or mean blood pressure < 65 mmHg, use of vasopressors; Glasgow Coma Scale score of 12 points or less)
- History of recent facial trauma not compatible with the use of nasal cannulas
- Pregnancy
- Refusal of study participation
- protected person
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 |
|---|---|---|
| HFNCIn the HFNC group, patients will receive HFNC oxygen therapy for 20 minutes. | Procedure or surgery | HFNC (Hight-flow oxygen therapy) |
| NIVPatients will receive NIV for 20 minutes delivered with a naso-buccal or face mask according to the patient's tolerance. | Procedure or surgery | Non-invasive ventilation (NIV) |
Primary outcome
Variation in poorly aerated lung volume
Time frame: the day of inclusion
The poorly aerated volume will be measured by CT scan
Variation in non-aereted lung volume
Time frame: the day of inclusion
The non-aereted volume will be measured by CT scan
9 secondary outcomes
Variation in cross-sectional upper airway area
Time frame: the day of inclusion
Variation in normally aerated lung volume
Time frame: the day of inclusion
Variation in Positive End Expiratory Pressure (PEEP)
Time frame: the day of inclusion
Variation in Total lung volume
Time frame: the day of inclusion
Variation in O2 gas exchange
Time frame: the day of inclusion
Variation in CO2 gas exchange
Time frame: the day of inclusion
Variation in respiratory rate
Time frame: the day of inclusion
Variation in cardiac output (Qc)
Time frame: the day of inclusion
Variation in patient comfort
Time frame: the day of inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Derived from this study: PubMed 40962342Monet C, Piron L, Pressac M, Molinari N, De Jong A, Guiu B, Jaber S. Study protocol for the HONIVAH trial: a single-centre randomised study assessing high-flow oxygen therapy versus non-invasive ventilation on lung volumes and the upper airway in hypoxemic critically ill patients. BMJ Open. 2025 Sep 16;15(9):e106340. doi: 10.1136/bmjopen-2025-106340.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HFNC and NIV in people with Respiratory Failure, run by University Hospital, Montpellier at 1 site 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 7 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: status not confirmed, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samir JABER (0033467337271, s-jaber@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in poorly aerated lung volume (time frame: the day of inclusion). The study lists 2 primary outcomes in all. 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 NCT05643911, which also lists 1 linked publication.
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 29 May 2024.