Oxygenation Procedure for Obese Patients During Intubation in the Operating Room

Not Applicable

Recruiting

• Conditions: Anesthesia Induction

• Registration Number: NCT06914401
• Lead Sponsor: Clinique Pasteur

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-28
• Study First Submitted QC: 2025-04-04
• Study First Posted: 2025-04-06
• Status Verified: 2025-06
• Study Start: 2025-06-19
• Last Update Submitted: 2025-06-27
• Last Update Posted: 2025-07-02
• Primary Completion: 2027-03
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Oxygen reserve	2 minutes after intubation	The lowest level of end-tidal oxygen concentration (EtO2)

Secondary Outcome Measures

Name	Time	Method
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
Adverse events	Perioperative/Periprocedural	moderate and severe complications
Patient tolerance	Day 2, at study end	Numerical Rating Scale (NRS); \[minimum value 0, maximum value 10\] higher score mean a better outcome

Trial Locations

Locations (1)

Clinique Pasteur; 🇫🇷 Toulouse, France