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
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