NCT06914401

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
124

participants targeted

Target at P50-P75 for not_applicable

Timeline
10mo left

Started Jun 2025

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress52%
Jun 2025Mar 2027

First Submitted

Initial submission to the registry

March 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

June 19, 2025

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 6, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

March 28, 2025

Last Update Submit

March 5, 2026

Conditions

Anesthesia Induction

Keywords

Non Invasive VentilationHigh Flow Nasal OxygenIntubationObese

Outcome Measures

Primary Outcomes (1)

  • Oxygen reserve

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

    2 minutes after intubation

Secondary Outcomes (4)

  • SpO2

    during preoxygenation; before intubation; during intubation; after intubation; 2 minutes after intubation

  • Rate of EtCO2

    2 minutes after intubation

  • Patient tolerance

    Day 2, at study end

  • Adverse events

    Perioperative/Periprocedural

Study Arms (2)

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)

Interventions

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

Combined oxygenation procedure
NIV (Non Invasive Ventilation)PROCEDURE

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

Single oxygenation procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Clermont Ferrand - Site Estaing

Clermont-Ferrand, 63100, France

RECRUITING

Clinique Honoré Cave

Montauban, 82000, France

RECRUITING

Hôpital Saint Eloi - CHU Montpellier

Montpellier, 34295, France

RECRUITING

Clinique Mutualiste La Sagesse

Rennes, 35000, France

RECRUITING

Clinique Pasteur

Toulouse, 31000, France

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

Noninvasive Ventilation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Respiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Ségolène MROZEK, MD, PhD

    Clinique Pasteur

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ségolène MROZEK, MD, PhD

CONTACT

+ 33 5 62 21 16 22smrozek@clinique-pasteur.com

Stéphanie SAVY, PhD

CONTACT

+ 33 5 62 21 30 12ssavy@clinique-pasteur.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 6, 2025

Study Start

June 19, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

March 6, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)