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

Nantes University Hospital (NUH)

Status: Completed

Conditions: Morbid Obesity; Ventilation Therapy; Complications

Treatments: Procedure: Ventilation with face mask; Procedure: No ventilation with face mask

Study type: Interventional

Funder types: Other

Identifiers

NCT05930678

RC22_0359

Details and patient eligibility

About

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.

Full 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)

Enrollment: 725 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

725 participants in 2 patient groups

Without ventilation

Active Comparator group

Description:

No ventilation sequence during the intubation period and without face mask ventilation during the apnea period

Treatment:

Procedure: No ventilation with face mask

With ventilation

Experimental group

Description:

Sequence "with ventilation" during the apnea period with face mask ventilation

Treatment:

Procedure: Ventilation with face mask