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RecruitingNCT06914401

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
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
124 (estimated)
Sponsor
Clinique Pasteur · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
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).

Timeline

Start date
2025-06-19
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2025-04-06
Last updated
2026-03-06

Locations

5 sites across 1 country: France

Source: ClinicalTrials.gov record NCT06914401. Inclusion in this directory is not an endorsement.