NCT05930678

Intubation of Obese Patients in the Operating Room With or Without Face Mask Ventilation

Intubation of Obese Patients in the Operating Room With or Without Face Mask Ventilation. A Randomized Multicentre Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 725 (actual)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to answer a daily question in the operating room: what is the safest technique for intubation of severe/morbid obese patients (BMI 35 or more). There is a great heterogeneity of practices on the subject, so the principle is to determine a common practice to facilitate the management of these patients.

Detailed description

Anesthesia consultation or pre-anesthesia visit: * screening for inclusion and non-inclusion criteria * patient information * collection of consent * inclusion D0 (day of inclusion): * before general anesthesia : collection of epidemiological data (history + clinical examinations) + randomization (Arm A/Not Vent : intubation without ventilation or Arm B/Vent : intubation with ventilation) * general anesthesia : intubation according to randomization arm + collection primary endpoint + conduct of the intubation procedure + morbidity of the intubation procedure * after general anesthesia : collection of secondary endpoints + conduct of the intubation procedure + morbidity of the intubation procedure + intraoperative respiratory morbidity * post-interventional care room : collection of clinical parameters in the ICU : postoperative morbidity + study discharge (hospital discharge)

Conditions

• Morbid Obesity
• Ventilation Therapy; Complications

Interventions

Type	Name	Description
PROCEDURE	No ventilation with face mask	During the period of apnea (in general anesthesia), the patient did not help with face mask
PROCEDURE	Ventilation with face mask	During the pperiod of apnea (in general anesthesia), the patient did help with face mask

Timeline

• Start date: 2023-09-12
• Primary completion: 2025-06-24
• Completion: 2025-07-03
• First posted: 2023-07-05
• Last updated: 2026-03-12

Locations

13 sites across 1 country: France