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Completed

NCT Number: NCT06914401

Oxygenation Procedure for Obese Patients During Intubation in the Operating Room

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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Key information

Conditions

Anesthesia Induction Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont Ferrand - Site Estaing, Clermont-Ferrand, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Procedure

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

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

Primary outcomes

  1. Oxygen reserve

    Time frame: 2 minutes after intubation

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

Secondary outcomes

  1. SpO2

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

    Peripheral oxygen saturation

  2. Rate of EtCO2

    Time frame: 2 minutes after intubation

    End-tidal carbon dioxide

  3. Patient tolerance

    Time frame: Day 2, at study end

    Numerical Rating Scale (NRS)

    [minimum value 0, maximum value 10] higher score mean a better outcome

  4. Adverse events

    Time frame: Perioperative/Periprocedural

    moderate and severe complications

Sponsors and collaborators

Lead sponsor

Clinique Pasteur

Other

Registry information

Official study 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

Acronym: POP-OVNI

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 6, 2025
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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