Oxygenation Procedure for Obese Patients During Intubation in the Operating Room

Clinique Pasteur124 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

124

Conditions

Anesthesia Induction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (5)

CHU Clermont Ferrand - Site Estaing

Clermont-Ferrand, France

Clinique Honoré Cave

Montauban, France

Hôpital Saint Eloi - CHU Montpellier

Montpellier, France

Clinique Mutualiste La Sagesse

Rennes, France

Clinique Pasteur

Toulouse, France

Outcomes

Primary Outcomes

Oxygen reserve

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

Time frame: 2 minutes after intubation

Secondary Outcomes

SpO2

Peripheral oxygen saturation

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

Rate of EtCO2

End-tidal carbon dioxide

Time frame: 2 minutes after intubation

Patient tolerance

Numerical Rating Scale (NRS) \[minimum value 0, maximum value 10\] higher score mean a better outcome

Time frame: Day 2, at study end

Adverse events

moderate and severe complications

Time frame: Perioperative/Periprocedural