Actively Recruiting
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
Led by Clinique Pasteur · Updated on 2026-03-06
124
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Obesity can increase the risk of difficult intubation and mask ventilation during anesthesia, partly because it reduces the lungs' oxygen reserve. Complications during anesthesia induction and intubation occur more often in obese patients, making proper oxygenation strategies important. This trial compares two oxygenation methods for obese patients undergoing general anesthesia with orotracheal intubation to find the best approach. The study evaluates oxygenation using a combination of Non-Invasive Ventilation (NIV) and High Flow Nasal Oxygen (HFNO) compared to NIV alone during induction in the operating room. In the combined group, preoxygenation is done with both NIV and HFNO, and during intubation, NIV is stopped while HFNO continues to provide oxygen. The other group receives preoxygenation with NIV only. Participants will be monitored for oxygen reserve two minutes after intubation, along with oxygen saturation levels at various stages before, during, and after intubation. Additional assessments include carbon dioxide levels, patient tolerance on day two, and any adverse events during the perioperative period. The study starts with screening and consent, followed by random assignment to one of the oxygenation methods, with ongoing monitoring throughout the procedure and shortly after.
CONDITIONS
Brief Title
Oxygenation Procedure for Obese Patients During Intubation in the Operating Room
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient requiring general anaesthesia with orotracheal intubation in the operating room
- Obese patient (Body Mass Index , BMI 65 30kg/m2)
- Patient affiliated to or benefiting from a social security scheme
- Patient having signed the free and informed consent form.
You will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - Single procedure during surgery
Participants receive one of two oxygenation procedures during intubation in the operating room to assess oxygen reserve and safety.
1 visit during surgery (in-person)
Duration - Up to 2 days post-procedure
Participants are monitored for oxygen saturation, tolerance, and any adverse events after the procedure.
1 follow-up visit on Day 2 (in-person)
Trial Site Locations
Total: 5 locations
1
CHU Clermont Ferrand - Site Estaing
Clermont-Ferrand, France, 63100
Actively Recruiting
2
Clinique Honoré Cave
Montauban, France, 82000
Actively Recruiting
3
Hôpital Saint Eloi - CHU Montpellier
Montpellier, France, 34295
Actively Recruiting
4
Clinique Mutualiste La Sagesse
Rennes, France, 35000
Actively Recruiting
5
Clinique Pasteur
Toulouse, France, 31000
Actively Recruiting
Research Team
S
Ségolène MROZEK, MD, PhD
S
Stéphanie SAVY, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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