Clinical trial NCT05930678: Intubation of Obese Patients in the Operating Room with or Without Bag-Mask Ventilation
Official title: Intubation of Obese Patients in the Operating Room with or Without Bag-Mask Ventilation. a Randomized Multicentre Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Morbid Obesity
Ventilation Therapy; Complications
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2023-07-05
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Morbidly obese patients (BMI greater than or equal to 35).
Primary purpose: SUPPORTIVE_CARE

Brief 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)

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

Primary outcomes:
measure: To compare the effectiveness of an intubation sequence "with ventilation during apnea" versus a sequence "without ventilation during apnea" in preventing complications related to intubation of the obese patient in the operating room
timeFrame: From induction of general anesthesia to 10 minutes after intubation
Secondary outcomes:
measure: Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
timeFrame: During the general anesthesia, up to 8 hours
measure: Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
timeFrame: During the general anesthesia, up to 10 minutes
measure: Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
timeFrame: During the general anesthesia, up to 10 minutes
measure: Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
timeFrame: During the general anesthesia, up to 8 hours
measure: Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
timeFrame: During the general anesthesia, up to 8 hours
measure: Impact of the nature of the intubation sequence on the progress of the intubation procedure between patient with face mask and patient without face mask
timeFrame: During the general anesthesia, up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on morbidity related to the intubation procedure between patient with face mask and patient without face mask
timeFrame: up to 8 hours
measure: Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
timeFrame: 5 minutes, 30 minutes and 1 hour after intubation
measure: Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
timeFrame: up to 28 days
measure: Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
timeFrame: up to 28 days
measure: Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
timeFrame: up to 28 days
measure: Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
timeFrame: up to 28 days
measure: Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
timeFrame: up to 28 days
measure: Impact of the nature of the intubation sequence on immediate intraoperative and postoperative respiratory morbidity between patient with face mask and patient without face mask
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Nantes
country: France
facility: CHU Nantes
state: Loire Atlantique
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHRU Brest
city: Dijon
country: France
facility: CHU de Dijon
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Lille
country: France
facility: CHRU de Lille - Hôpital Claude Huriez
city: Lyon
country: France
facility: HCL - Hôpital Edouard Herriot
city: Nantes
country: France
facility: CHU de Nantes - site Laennec
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Nazaire
country: France
facility: CH de Saint-Nazaire
city: Saint-Nazaire
country: France
facility: Clinique Mutualiste de l'Estuaire
city: Toulouse
country: France
facility: CHU Toulouse
city: Valenciennes
country: France
facility: CH de Valenciennes
Study officials:
affiliation: Nantes University Hospital
name: Mickael VOURC'H, PhD
role: PRINCIPAL_INVESTIGATOR
References: