Oxygenation Procedure for Obese Patients During Intubation in the Operating Room (POP-OVNI)

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.

Study Overview

• Status: Recruiting
• Conditions: Anesthesia Induction
• Intervention / Treatment: Procedure: NIV (Non Invasive Ventilation) and HFNO (High Flow Nasal Oxygen); Procedure: NIV (Non Invasive Ventilation)

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ségolène MROZEK, MD, PhD; Phone Number: + 33 5 62 21 16 22; Email: smrozek@clinique-pasteur.com
• Study Contact Backup: Name: Stéphanie SAVY, PhD; Phone Number: + 33 5 62 21 30 12; Email: ssavy@clinique-pasteur.com

Study Locations

• France
  • Clermont-Ferrand, France, 63100
    • Recruiting
    • CHU Clermont Ferrand - Site Estaing
    • Principal Investigator: Thomas GODET, MD
  • Montauban, France, 82000
    • Recruiting
    • Clinique Honoré Cave
    • Principal Investigator: Frédéric BELLEC, MD
  • Montpellier, France, 34295
    • Recruiting
    • Hopital Saint Eloi - CHU Montpellier
    • Principal Investigator: Audrey DE JONG, MD
  • Rennes, France, 35000
    • Recruiting
    • Clinique mutualiste La Sagesse
    • Principal Investigator: Marc ANGER, MD
  • Toulouse, France, 31000
    • Recruiting
    • Clinique Pasteur
    • Principal Investigator: Ségolène MROZEK, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Combined oxygenation procedure	Procedure: 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
Active Comparator: Single oxygenation procedure	Procedure: NIV (Non Invasive Ventilation); Single procedure Preoxygenation prior to intubation with NIV (Non Invasive Ventilation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oxygen reserve	The lowest level of end-tidal oxygen concentration (EtO2)	2 minutes after intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient tolerance	Numerical Rating Scale (NRS) [minimum value 0, maximum value 10] higher score mean a better outcome	Day 2, at study end
Adverse events	moderate and severe complications	Perioperative/Periprocedural
SpO2	Peripheral oxygen saturation	during preoxygenation; before intubation; during intubation; after intubation; 2 minutes after intubation
Rate of EtCO2	End-tidal carbon dioxide	2 minutes after intubation

Collaborators and Investigators

• Sponsor: Clinique Pasteur
• Investigators: Principal Investigator: Ségolène MROZEK, MD, PhD, Clinique Pasteur

Study record dates

Study Major Dates

• Study Start (Actual): June 19, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 28, 2025
• First Submitted That Met QC Criteria: April 4, 2025
• First Posted (Actual): April 6, 2025

Study Record Updates

• Last Update Posted (Actual): March 6, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Obese; Intubation; Non Invasive Ventilation; High Flow Nasal Oxygen
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Therapeutics; Airway Management; Respiratory Therapy; Respiration, Artificial; Noninvasive Ventilation
• Other Study ID Numbers: 2024-A02304-43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No