Respiratory FailureVNI-HDNCT02389166
Optiflow in Sequential Non-Invasive Ventilation
A study testing Optiflow and Conventional oxygen therapy in people with Respiratory Failure, run by University Hospital, Bordeaux at 8 sites in France.
Trial summary
Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du… 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?
- Optiflow and Conventional oxygen therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 8 sitesFrance
- Study dates
- 25 Jun 2015to 5 Mar 2019
- 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 at least 18 years old
- Patients affiliated to or benefiting of the French social welfare system
- Patients with ARDS on previously healthy lung. Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio less than 200 mm Hg associated with the presence of lung infiltrates on chest radiograph
- Free and informed consent of patient
- Hospitalized in one of involved ICU
Who cannot join
- Existence of criteria for intubation.
- Refusal to participate in the study.
- Pregnancy
- Patient under guardianship or trusteeship
- Patients for whom a decision of non intubation has been decided.
- Patients who have received one or several NIV session for ARDS before hospital admission
Show all 20Show fewer
- Home noninvasive ventilation
- Tracheostomy
- Hemodynamic instability
- Hypercapnia (PaCO2>45 mm Hg).
- left ventricular failure (cardiogenic pulmonary acute edema).
- Ineffective coughing.
- Recent gastric or oesophageal surgery
- Severe ventricular rhythm disorder
- High digestive haemorrhage
- Lack of collaboration
- Pernicious vomiting
- Upper airway obstruction
- Severe sepsis.
- Undrained pneumothorax.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Service de Réanimation Polyvalente - CH d'Agen
Agen, 47923
Réanimation polyvalente - CH d'Albi
Albi, 81000
Service de réanimation - CH de la côte basque
Bayonne, Aquitaine, 64100
Service de réanimation médicale - CHU de Bordeaux
Bordeaux, Aquitaine, 33000
Service de Réanimation Polyvalente - CH de Libourne
Libourne, Aquitaine, 33505
Réanimation Polyvalente - CH de Mont de Marsan
Mont-de-Marsan, 40024
Service de Réanimation - CH de Perigueux
Périgueux, Aquitiane, 24000
Service de Réanimation Polyvalente - CHU de Toulouse
Toulouse, Midi-pyrenees, 31059
About this study
Official title: Randomized Clinical Trial Comparing High Flow Oxygen Delivery System (Optiflow) With Oxygen Therapy Under High-concentration Mask on Oxygenation of Patients Who Receive Sequential Non-Invasive Ventilation (NIV) Sessions
Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. In observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory failure. Oxygenation is better than under high-concentration mask and work of breathing is reduced.
The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session), during the first two NIV sessions
Read more
Study design : Prospective, randomized, controlled, multicentric, open clinical trial with two groups:
- control group with conventional clinical management, oxygen therapy and sequential used of NIV
- Optiflow group with high flow oxygen delivery system, conventional clinical management and sequential used of NIV for a period of 36 hours at least.
Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for hypoxemic respiratory failure.
- Conditions
- Respiratory Failure
- Being tested
- Optiflow, Conventional oxygen therapy
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OptiflowDevice
Patients receive high flow oxygen delivery system, Optiflow, conventional clinical management and sequential used of NIV for a period of 36 hours at least.
High flow oxygen nasal therapy (Optiflow) : The flow will be set at 40l/min to 60l/min The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a SaO2 between 94% and 98%.
Conventional oxygen therapyDevice
Patients receive conventional oxygen therapy with high concentration mask, conventional clinical management, and sequential use of NIV Conventional oxygen therapy: The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a Arterial Oxygen Saturation (SaO2) between 94% and 98%.
| Study group | Role | What they receive |
|---|---|---|
| Optiflow group | Experimental | Not described Receives: Device: Optiflow |
| Control group | Active comparator | Not described Receives: Device: Conventional oxygen therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average of oxygenation differences measured as the delta between PaO2/FiO2ratio at the end of the first ans second NIV session and at the end of the first and second oxygen therapy session.
Average of oxygenation differences measured as the delta between PaO2/FiO2 ratio at the end of the first NIV session and at the end of the first oxygen therapy session (according group of treatment) on the one hand and on the other hand the delta between PaO2/FiO2 ratio at the end of the second NIV session and at the end of the second oxygen thrapy session
Five measurements of PaO2/FiO2 ratio are realized with arterial blood gases:
- at the time of inclusion,
- at the time of the end of first NIV session,
- at the time of the end of first oxygen therapy session, or at the time of rescue NIV or at the time of réintubation
- at the time of the end of second NIV session,
- at the time of the end of second oxygen therapy session These five measurements are usually realised, and they are important to optimize patient management. The primary endpoint is based on these five measurements.
Measured: 28 days
Secondary outcomes (9)
comfort score dyspnea beetween the two NIV sessions
The comfort score and dyspnea will be assessed between the two NIV sessions
Measured: 28 days
Incidence of serious adverse events between the two NIV sessions
Measured: 28 days
Respiratory rate between the two NIV sessions
Respiratory rate to assess work of breathing between the two NIV sessions
Measured: 28 days
incidence of intubation during the NIV treatment of Acute respiratory distress syndrome (ARDS)
Measured: 28 days
ICU mortality
Measured: 28 days
28 days survival
Measured: 28 days
Hospital mortality
Measured: 28 days
ICU length of stay
Measured: 28 days
duration of mechanical ventilation
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2015 (estimated)
- Study start25 Jun 2015
- Primary completion5 Feb 2019
- Study completion5 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine BENARD, Docotor, Study chair, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02389166
- Sponsor's protocol ID
- CHUBX 2013/28
- Other IDs
- 2014-A01098-39
- Acronym
- VNI-HD
- Status last verified
- Jul 2019
- First submitted
- 3 Mar 2015
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing High Flow Oxygen Delivery System (Optiflow) With Oxygen Therapy Under High-concentration Mask on Oxygenation of Patients Who Receive Sequential Non-Invasive Ventilation (NIV) Sessions
- ClinicalTrials.gov ID
- NCT02389166
- Acronym / sponsor ID
- VNI-HD / CHUBX 2013/28
- Conditions
- Respiratory Failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 25 Jun 2015 (actual)
- Primary completion
- 5 Feb 2019 (actual)
- Study completion
- 5 Mar 2019 (actual)
- First posted
- 17 Mar 2015 (estimated)
- 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.
Background : Patient with hypoxemic respiratory failure treated with NIV receive between NIV session oxygen therapy. Gaz exchange disorder with a decrease of the ratio between Partial Pressure of Arterial Oxygen (PaO2) and Inspired Fraction of Oxygen (FIO2) are noticed when NIV is stopped at the end of the session du to alveolar derecruitment Optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. In observational studies, Optiflow increase oxygenation of patients with hypoxemic respiratory failure. Oxygenation is better than under high-concentration mask and work of breathing is reduced.
The aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between NIV sessions (measured as the difference between PaO2/FiO2 ratio at the beginning and at the end of the session), during the first two NIV sessions
Study design : Prospective, randomized, controlled, multicentric, open clinical trial with two groups:
- control group with conventional clinical management, oxygen therapy and sequential used of NIV
- Optiflow group with high flow oxygen delivery system, conventional clinical management and sequential used of NIV for a period of 36 hours at least.
Number of subjects: 100 (50 patients per group) patients admitted in intensive Care Unit for hypoxemic respiratory failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Optiflow group | Experimental | Device: Optiflow |
| Control group | Active comparator | Device: Conventional oxygen therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient at least 18 years old
- Patients affiliated to or benefiting of the French social welfare system
- Patients with ARDS on previously healthy lung. Acute respiratory insufficiency, defined as the PaO2/FIO2 ratio less than 200 mm Hg associated with the presence of lung infiltrates on chest radiograph
- Free and informed consent of patient
- Hospitalized in one of involved ICU
Key exclusion criteria (20 listed)
- Existence of criteria for intubation.
- Refusal to participate in the study.
- Pregnancy
- Patient under guardianship or trusteeship
- Patients for whom a decision of non intubation has been decided.
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 |
|---|---|---|
| OptiflowPatients receive high flow oxygen delivery system, Optiflow, conventional clinical management and sequential used of NIV for a period of 36 hours at least. High flow oxygen nasal therapy (Optiflow) : The flow will be set at 40l/min to 60l/min The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a SaO2 between 94% and 98%. | Device | Optiflow group |
| Conventional oxygen therapyPatients receive conventional oxygen therapy with high concentration mask, conventional clinical management, and sequential use of NIV Conventional oxygen therapy: The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a Arterial Oxygen Saturation (SaO2) between 94% and 98%. | Device | Control group |
Primary outcome
Average of oxygenation differences measured as the delta between PaO2/FiO2ratio at the end of the first ans second NIV session and at the end of the first and second oxygen therapy session.
Time frame: 28 days
Average of oxygenation differences measured as the delta between PaO2/FiO2 ratio at the end of the first NIV session and at the end of the first oxygen therapy session (according group of treatment) on the one hand and on the other hand the delta between PaO2/FiO2 ratio at the end of the second NIV session and at the end of the second oxygen thrapy session Five measurements of PaO2/FiO2 ratio are realized with arterial blood gases: * at the time of inclusion, * at the time of the end of first NIV session, * at the time of the end of first oxygen therapy session, or at the time of rescue NIV or at the time of réintubation * at the time of the end of second NIV session, * at the time of the end of second oxygen therapy session These five measurements are usually realised, and they are important to optimize patient management. The primary endpoint is based on these five measurements.
9 secondary outcomes
comfort score dyspnea beetween the two NIV sessions
Time frame: 28 days
Incidence of serious adverse events between the two NIV sessions
Time frame: 28 days
Respiratory rate between the two NIV sessions
Time frame: 28 days
incidence of intubation during the NIV treatment of Acute respiratory distress syndrome (ARDS)
Time frame: 28 days
ICU mortality
Time frame: 28 days
28 days survival
Time frame: 28 days
Hospital mortality
Time frame: 28 days
ICU length of stay
Time frame: 28 days
duration of mechanical ventilation
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
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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.
Antoine BENARD, Docotor study chair
University Hospital, Bordeaux
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optiflow and Conventional oxygen therapy in people with Respiratory Failure, run by University Hospital, Bordeaux at 8 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 5 inclusion and 20 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: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average of oxygenation differences measured as the delta between PaO2/FiO2ratio at the end of the first ans second NIV session and at the end of the first and second oxygen therapy session. (time frame: 28 days). 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 22 May 2026.