Intubation techniques for obese patients in the operating room

Intubation of Obese Patients in the Operating Room with or Without Bag-Mask Ventilation. a Randomized Multicentre Study

This study is testing which intubation method is safer for people with severe obesity during surgery to help improve their care in the operating room.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 702 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Nantes University Hospital (Academic / other)
• Locations: 13 sites (Nantes, Loire Atlantique and 12 other locations)
• Trial ID: NCT05930678 on ClinicalTrials.gov

What this trial studies

This study aims to determine the safest intubation technique for patients with severe or morbid obesity (BMI 35 or more) during general anesthesia. Participants will be randomized into two groups: one receiving intubation without bag-mask ventilation and the other with bag-mask ventilation. The study will collect various clinical data before, during, and after the intubation procedure to assess morbidity and respiratory complications. The goal is to establish a common practice for managing these patients in the operating room.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 years old with a BMI of 35 or higher requiring general anesthesia for surgery.

Not a fit: Patients with urgent surgical needs, significant respiratory issues, or contraindications to mask ventilation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the safety and outcomes of intubation procedures in morbidly obese patients.

How similar studies have performed: Other studies have explored intubation techniques in obese patients, but this specific comparison of ventilation methods is novel.

Eligibility criteria

Inclusion criteria:

* patient requiring general anesthesia with intubation for surgery or scheduled endoscopic procedures
* age \> 18 years
* with a BMI superior or equal to 35kg.m-²
* patient having signed an informed consent

Non-inclusion criteria:

* ambient air saturation \<90%
* urgent surgery \< 24 hours
* cardio-thoracic surgery
* mask ventilation not possible (e.g. ATCD, cervical irradiation, fixed mandible)
* formal contraindication to mask ventilation (e.g. occlusive syndrome, non fasting patient, symptomatic gastroesophageal reflux untreated or persistent under treatment)
* wish of the operator for high flow oxygen preoxygenation
* wish of an intubation without curare by the operator
* pregnant or breast-feeding women
* protected adults (guardianship, curatorship or safeguard of justice)
* participation in another randomized clinical research study concerning preoxygenation and relevant to the primary endpoint
* absence of affiliation to the French social security system

Where this trial is running

Nantes, Loire Atlantique and 12 other locations

• CHU Nantes — Nantes, Loire Atlantique, France (Recruiting)
• CHU Angers — Angers, France (Recruiting)
• CHRU Brest — Brest, France (Recruiting)
• CHU de Dijon — Dijon, France (Recruiting)
• CHD Vendée — La Roche sur Yon, France (Recruiting)
• CHRU de Lille - Hôpital Claude Huriez — Lille, France (Recruiting)
• HCL - Hôpital Edouard Herriot — Lyon, France (Recruiting)
• CHU de Nantes - site Laennec — Nantes, France (Recruiting)
• CHU de Rennes — Rennes, France (Recruiting)
• CH de Saint-Nazaire — Saint-Nazaire, France (Recruiting)
• Clinique Mutualiste de l'Estuaire — Saint-Nazaire, France (Recruiting)
• CHU Toulouse — Toulouse, France (Recruiting)
• CH de Valenciennes — Valenciennes, France (Recruiting)

Study contacts

• Principal investigator: Mickael VOURC'H, PhD — Nantes University Hospital
• Study coordinator: Mickael VOURC'H, PhD

Conditions Morbid Obesity; Ventilation Therapy; Complications