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CompletedNCT06914401POP-OVNIUpdated Jun 15, 2026

Oxygenation Procedure for Obese Patients During Intubation in the Operating Room

An interventional study of NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen) and NIV (Non Invasive Ventilation) in Anesthesia Induction, sponsored by Clinique Pasteur. Completed at 5 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Clinique Pasteur · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Anesthesia Induction

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Keywords

  • Non Invasive Ventilation
  • High Flow Nasal Oxygen
  • Intubation
  • Obese
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In context

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

This study's enrollment of 124 is above the median of 67 across 9,006 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Clinique Pasteur is the lead sponsor of 15 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient requiring general anaesthesia with orotracheal intubation in the operating room
  • Obese patient ( , BMI ≥ 30kg/m2)
  • Patient affiliated to or benefiting from a social security scheme
  • Patient having signed the free and form.

Exclusion criteria

Exclusion Criteria:

  • Haemodynamic instability
  • Intubation without laryngoscopy (fibroscope intubation) or nasotracheal intubation
  • Emergency surgery not allowing patient consent.
  • Patient with a 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
124 participants (actual)

Study arms

  • Active comparator
    Combined oxygenation procedure

    Procedure: NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen)

  • Active comparator
    Single oxygenation procedure

    Procedure: NIV (Non Invasive Ventilation)

Interventions

  • ProcedureNIV (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

  • ProcedureNIV (Non Invasive Ventilation)

    Single procedure Preoxygenation prior to intubation with NIV (Non Invasive Ventilation).

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What researchers measure

Primary outcomes

  1. Oxygen reserve

    The lowest level of end-tidal oxygen concentration (EtO2)

    Time frame: 2 minutes after intubation

Secondary outcomes

  1. SpO2

    Peripheral oxygen saturation

    Time frame: during preoxygenation; before intubation; during intubation; after intubation; 2 minutes after intubation

  2. Rate of EtCO2

    End-tidal carbon dioxide

    Time frame: 2 minutes after intubation

  3. Patient tolerance

    Numerical Rating Scale (NRS) \[minimum value 0, maximum value 10\] higher score mean a better outcome

    Time frame: Day 2, at study end

  4. Adverse events

    moderate and severe complications

    Time frame: Perioperative/Periprocedural

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Study locations

5 sites
  • CHU Clermont Ferrand - Site Estaing
    Clermont-Ferrand, 63100, France
  • Clinique Honoré Cave
    Montauban, 82000, France
  • Hôpital Saint Eloi - CHU Montpellier
    Montpellier, 34295, France
  • Clinique Mutualiste La Sagesse
    Rennes, 35000, France
  • Clinique Pasteur
    Toulouse, 31000, France
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06914401
Lead sponsor
Clinique Pasteur
Responsible party
Sponsor
First posted
Apr 6, 2025
Start date
Jun 19, 2025
Primary completion
May 4, 2026
Completion
May 4, 2026
Last update
Jun 15, 2026

Study contacts

Ségolène MROZEK, MD, PhD
principal investigator · Clinique Pasteur

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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