Oxygenation Procedure for Obese Patients During Intubation in the Operating Room

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06914401

Acronym

POP-OVNI

Enrollment

124

Registered

2025-04-06

Start date

2025-06-19

Completion date

2026-05-04

Last updated

2026-06-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Induction

Keywords

Non Invasive Ventilation, High Flow Nasal Oxygen, Intubation, Obese

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.

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).

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

France

Contacts

PRINCIPAL_INVESTIGATORSégolène MROZEK, MD, PhD

Clinique Pasteur

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 16, 2026