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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

725 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-12

Study Completion Date

2025-07-03

Brief Summary

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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.

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Detailed Description

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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

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Morbid Obesity Ventilation Therapy; Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Morbidly obese patients (BMI greater than or equal to 35).

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Without ventilation

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

Group Type ACTIVE_COMPARATOR

No ventilation with face mask

Intervention Type PROCEDURE

During the period of apnea (in general anesthesia), the patient did not help with face mask

With ventilation

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

Group Type EXPERIMENTAL

Ventilation with face mask

Intervention Type PROCEDURE

During the pperiod of apnea (in general anesthesia), the patient did help with face mask

Interventions

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Ventilation with face mask

During the pperiod of apnea (in general anesthesia), the patient did help with face mask

Intervention Type PROCEDURE

No ventilation with face mask

During the period of apnea (in general anesthesia), the patient did not help with face mask

Intervention Type PROCEDURE

Eligibility Criteria

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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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No