RecruitingNot ApplicableNCT06914401

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

Sponsor

Clinique Pasteur

Enrollment

124 participants

Start Date

Jun 19, 2025

Study Type

INTERVENTIONAL

Conditions

Anesthesia Induction

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria5

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.

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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).