Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation — VENT OR NOT  

Morbid Obesity Clinical Trial

Official title: Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation. A Randomized Multicentre Study

Status Recruiting

Clinical Trial 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.

Clinical Trial 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) ;

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Ventilation Therapy; Complications

• NCT number: NCT05930678
• Study type: Interventional
• Source: Nantes University Hospital
• Contact: Mickael VOURC'H, PhD
• Phone: 0244768053
• Email: mickael.vourch@chu-nantes.fr
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Completion date: September 12, 2025