ICUOVNINCT04036175
Comparison of Patient Work of Breathing and Tidal Volumes With High Flow Nasal Cannula Oxygen Therapy and NIV (Non-Invasive Ventilation) After Extubation in the ICU.
A study testing High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen in people with ICU and Extubation, run by Poitiers University Hospital at 2 sites in France.
Trial summary
This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ICU, Extubation, Non-invasive Ventilation
- What is being tested?
- High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 6 Mar 2018to 6 Mar 2020
- 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
- Minimum age: 18 years
- planned extubation decided by the physician in charge of the patient after success of weaning trial
- patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease
- Hypoxemia defined by PaO2/FiO2 < 300 mmHg under mechanical ventilation before extubation
Who cannot join
- Duration of mechanical ventilation prior to extubation < 24h
- Contraindication to NIV
- Contraindication to nasogastric tube
- Do-not-reintubated order at time of extubation
- People under legal protection
- Opposition to participate
Trial locations and contacts
2 sites in 1 country.
Céline DELETAGE contact
France2 sites, 2 recruiting
- Recruiting
CHU Poitiers
Poitiers, 86000
Arnaud W THILLE, Pr, 05 49 44 38 54, arnaud.thille@chu-poitiers.fr
- Recruiting
Intensive reanimation
Poitiers, 86000
Arnaud THILLE, +33 5 49 44 38 54
Jean-Pierre FRAT, +33 5 49 44 38 54
About this study
Official title: Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study
This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.
- Conditions
- ICU, Extubation, Non-invasive Ventilation, High-Flow Nasal Oxygen Therapy, Respiratory Effort, Work of Breathing
- Being tested
- High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygenDevice
Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2>= 92%
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Other | Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition) Receives: Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen |
| Group 2 | Other | Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition) Receives: Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient respiratory effort and tidal volume (Vt)
Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography
Measured: 1h20
Secondary outcomes (6)
Respiratory parameters
respiratory rate (FR bt/min)
Measured: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters
saturation (SpO2 in %)
Measured: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters
transcutaneous CO2 pressure (PCO2 in mm Hg)
Measured: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters
transpulmonary pressure (cm H2O)
Measured: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Hemodynamic parameters
Systolic arterial pressure (PAS in mmHg), Diastolic arterial pressure (PAD in mmHg)
Measured: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Comfort evaluation
comfort evaluation with an visual evaluation scale graduate 0 cm (No discomfort) to 10 cm (maximal discomfort)
Measured: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2019
- Study start6 Mar 2018
- Primary completion6 Mar 2020 (estimated)
- Study completion6 Mar 2020 (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 ICUStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud W. THILLE, PUPH, Principal investigator, Medecine intensive reanimation CHU Poitiers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04036175
- Sponsor's protocol ID
- 2017-A02838-45
- Acronym
- OVNI
- Status last verified
- Jul 2019
- First submitted
- 17 Jun 2019
- Last updated
- 31 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Arrive F, Le Pape S, Bruhn A, Pepin Lehalleur A, Beuvon C, Tuffet S, Etien E, Rambault L, Frat JP, Coudroy R, Thille AW. Physiological comparison of noninvasive ventilation and high-flow nasal oxygen on inspiratory efforts and tidal volumes after extubation: a randomized crossover trial. Crit Care. 2025 May 8;29(1):185. doi: 10.1186/s13054-025-05366-y.
PubMed 40341100Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.
PubMed 33661521
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04036175
- Acronym / sponsor ID
- OVNI / 2017-A02838-45
- Conditions
- ICU, Extubation, Non-invasive Ventilation, High-Flow Nasal Oxygen Therapy, Respiratory Effort, Work of Breathing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 6 Mar 2020 (estimated)
- Study completion
- 6 Mar 2020 (estimated)
- First posted
- 29 Jul 2019 (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.
This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Other | Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygenStandard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition) |
| Group 2 | Other | Device: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygenStandard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Minimum age: 18 years
- planned extubation decided by the physician in charge of the patient after success of weaning trial
- patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease
- Hypoxemia defined by PaO2/FiO2 < 300 mmHg under mechanical ventilation before extubation
Key exclusion criteria (6 listed)
- Duration of mechanical ventilation prior to extubation < 24h
- Contraindication to NIV
- Contraindication to nasogastric tube
- Do-not-reintubated order at time of extubation
- People under legal protection
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 |
|---|---|---|
| High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygenDevice High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2>= 92% | Device | Group 1, Group 2 |
Primary outcome
Patient respiratory effort and tidal volume (Vt)
Time frame: 1h20
Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography
6 secondary outcomes
Respiratory parameters
Time frame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters
Time frame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters
Time frame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Respiratory parameters
Time frame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Hemodynamic parameters
Time frame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Comfort evaluation
Time frame: "Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min"
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Derived from this study: PubMed 40341100Arrive F, Le Pape S, Bruhn A, Pepin Lehalleur A, Beuvon C, Tuffet S, Etien E, Rambault L, Frat JP, Coudroy R, Thille AW. Physiological comparison of noninvasive ventilation and high-flow nasal oxygen on inspiratory efforts and tidal volumes after extubation: a randomized crossover trial. Crit Care. 2025 May 8;29(1):185. doi: 10.1186/s13054-025-05366-y.
- Derived from this study: PubMed 33661521Lewis SR, Baker PE, Parker R, Smith AF. High-flow nasal cannulae for respiratory support in adult intensive care patients. Cochrane Database Syst Rev. 2021 Mar 4;3(3):CD010172. doi: 10.1002/14651858.CD010172.pub3.
- Individual participant dataSharing planned: Undecided
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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.
Céline DELETAGE contact
Arnaud W. THILLE, PUPH principal investigator
Medecine intensive reanimation CHU Poitiers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen in people with ICU and Extubation, run by Poitiers University Hospital at 2 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 4 inclusion and 6 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud W. THILLE, PUPH (+33 5 49 44 38 54, arnaud.thille@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient respiratory effort and tidal volume (Vt) (time frame: 1h20). 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 NCT04036175, 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 31 Jul 2019.