Anesthesia InductionPOP-OVNINCT06914401
Oxygenation Procedure for Obese Patients During Intubation in the Operating Room
A study testing NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) and NIV (Non Invasive Ventilation) in people with Anesthesia Induction, run by Clinique Pasteur at 5 sites in France.
Trial summary
Obesity is a risk factor for difficult intubation, with an incidence of up to 15.5%, and difficult mask ventilation. Obesity also reduces the functional residual capacity (FRC) of the lungs, the main reservoir of oxygen during apnoea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia Induction
- What is being tested?
- NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) and NIV (Non Invasive Ventilation)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 5 sitesFrance
- Study dates
- 19 Jun 2025to 4 May 2026
- 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 requiring general anaesthesia with orotracheal intubation in the operating room
- Obese patient (Body Mass Index , BMI ≥ 30kg/m2)
- Patient affiliated to or benefiting from a social security scheme
- Patient having signed the free and informed consent form.
Who cannot join
- Haemodynamic instability
- Intubation without laryngoscopy (fibroscope intubation) or nasotracheal intubation
- Emergency surgery not allowing patient consent.
- Patient with a contraindication to NIV or OHD
- Protected patients: Adults under guardianship, curatorship or other legal protection; deprived of liberty by judicial or administrative decision; pregnant, breast-feeding or parturient women; hospitalised without consent.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU Clermont Ferrand - Site Estaing
Clermont-Ferrand, 63100
Clinique Honoré Cave
Montauban, 82000
Hôpital Saint Eloi - CHU Montpellier
Montpellier, 34295
Clinique Mutualiste La Sagesse
Rennes, 35000
Clinique Pasteur
Toulouse, 31000
About this study
Official title: Oxygenation Procedure for Obese Patients Using High Flow Oxygen Therapy Combined With Non-invasive Ventilation During Intubation in the Operating Room: a Randomised Controlled Trial
Obesity is a risk factor for difficult intubation, with an incidence of up to 15.5%, and difficult mask ventilation. Obesity also reduces the functional residual capacity (FRC) of the lungs, the main reservoir of oxygen during apnoea. Complications associated with induction and intubation in the operating room are more frequent in obese patients. Preoxygenation is a cornerstone in the management of patients at risk of desaturation during induction. The study aims to compare two oxygenation strategies , in obese patients. Oxygenation using a combination of NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) compared with NIV alone in the operating room for induction of general anaesthesia with orotracheal intubation.
- Conditions
- Anesthesia Induction
- Being tested
- NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen), NIV (Non Invasive Ventilation)
- Keywords
- Non Invasive Ventilation, High Flow Nasal Oxygen, Intubation, Obese
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen)Procedure or surgery
Combination of two procedures Preoxygenation prior to intubation with NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen).
During intubation, NIV is stopped and apneic oxygenation is maintained with HFNO
NIV (Non Invasive Ventilation)Procedure or surgery
Single procedure Preoxygenation prior to intubation with NIV (Non Invasive Ventilation).
| Study group | Role | What they receive |
|---|---|---|
| Combined oxygenation procedure | Active comparator | Not described Receives: Procedure: NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) |
| Single oxygenation procedure | Active comparator | Not described Receives: Procedure: NIV (Non Invasive Ventilation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen reserve
The lowest level of end-tidal oxygen concentration (EtO2)
Measured: 2 minutes after intubation
Secondary outcomes (4)
SpO2
Peripheral oxygen saturation
Measured: during preoxygenation; before intubation; during intubation; after intubation; 2 minutes after intubation
Rate of EtCO2
End-tidal carbon dioxide
Measured: 2 minutes after intubation
Patient tolerance
Numerical Rating Scale (NRS)
[minimum value 0, maximum value 10] higher score mean a better outcome
Measured: Day 2, at study end
Adverse events
moderate and severe complications
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start19 Jun 2025
- Primary completion4 May 2026
- Study completion4 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia InductionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Pasteur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ségolène MROZEK, MD, PhD, Principal investigator, Clinique Pasteur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06914401
- Sponsor's protocol ID
- 2024-A02304-43
- Acronym
- POP-OVNI
- Status last verified
- Jun 2026
- First submitted
- 28 Mar 2025
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oxygenation Procedure for Obese Patients Using High Flow Oxygen Therapy Combined With Non-invasive Ventilation During Intubation in the Operating Room: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT06914401
- Acronym / sponsor ID
- POP-OVNI / 2024-A02304-43
- Conditions
- Anesthesia Induction
- Keywords
- Non Invasive Ventilation, High Flow Nasal Oxygen, Intubation, Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Clinique PasteurUniversity, hospital or other
- Study start
- 19 Jun 2025 (actual)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 6 Apr 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.
Obesity is a risk factor for difficult intubation, with an incidence of up to 15.5%, and difficult mask ventilation. Obesity also reduces the functional residual capacity (FRC) of the lungs, the main reservoir of oxygen during apnoea. Complications associated with induction and intubation in the operating room are more frequent in obese patients. Preoxygenation is a cornerstone in the management of patients at risk of desaturation during induction. The study aims to compare two oxygenation strategies , in obese patients. Oxygenation using a combination of NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) compared with NIV alone in the operating room for induction of general anaesthesia with orotracheal intubation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined oxygenation procedure | Active comparator | Procedure: NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) |
| Single oxygenation procedure | Active comparator | Procedure: NIV (Non Invasive Ventilation) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient requiring general anaesthesia with orotracheal intubation in the operating room
- Obese patient (Body Mass Index , BMI ≥ 30kg/m2)
- Patient affiliated to or benefiting from a social security scheme
- Patient having signed the free and informed consent form.
Key exclusion criteria (5 listed)
- Haemodynamic instability
- Intubation without laryngoscopy (fibroscope intubation) or nasotracheal intubation
- Emergency surgery not allowing patient consent.
- Patient with a contraindication to NIV or OHD
- Protected patients: Adults under guardianship, curatorship or other legal protection; deprived of liberty by judicial or administrative decision; pregnant, breast-feeding or parturient women; hospitalised without consent.
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 |
|---|---|---|
| NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen)Combination of two procedures Preoxygenation prior to intubation with NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen). During intubation, NIV is stopped and apneic oxygenation is maintained with HFNO | Procedure or surgery | Combined oxygenation procedure |
| NIV (Non Invasive Ventilation)Single procedure Preoxygenation prior to intubation with NIV (Non Invasive Ventilation). | Procedure or surgery | Single oxygenation procedure |
Primary outcome
Oxygen reserve
Time frame: 2 minutes after intubation
The lowest level of end-tidal oxygen concentration (EtO2)
4 secondary outcomes
SpO2
Time frame: during preoxygenation; before intubation; during intubation; after intubation; 2 minutes after intubation
Rate of EtCO2
Time frame: 2 minutes after intubation
Patient tolerance
Time frame: Day 2, at study end
Adverse events
Time frame: Perioperative/Periprocedural
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 15 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Ségolène MROZEK, MD, PhD principal investigator
Clinique Pasteur
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) and NIV (Non Invasive Ventilation) in people with Anesthesia Induction, run by Clinique Pasteur at 5 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 5 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Oxygen reserve (time frame: 2 minutes after intubation). 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 15 Jun 2026; AzTrials last refreshed its copy on 26 Oct 2026.