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

Not Applicable

Recruiting

• Conditions: Ventilation Therapy; Complications; Morbid Obesity
• Interventions: Procedure: No ventilation with face mask; Procedure: Ventilation with face mask

• Registration Number: NCT05930678
• Lead Sponsor: Nantes University Hospital

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)

Study Timeline

• Study First Submitted: 2023-06-01
• Study First Submitted QC: 2023-06-30
• Study First Posted: 2023-07-05
• Study Start: 2023-09-12
• Status Verified: 2024-10
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-09-12
• Study Completion: 2025-09-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 702

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without ventilation	No ventilation with face mask	No ventilation sequence during the intubation period and without face mask ventilation during the apnea period
With ventilation	Ventilation with face mask	Sequence "with ventilation" during the apnea period with face mask ventilation

Primary Outcome Measures

Name	Time	Method
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	From induction of general anesthesia to 10 minutes after intubation	Comparison of the incidence of intubation-related complications. Complications identified for the primary endpoint will be: desaturations \< 95%, need for 2 or more intubation attempts (including alternative technique), occurrence of inhalation/regurgitation or hypotension with systolic blood pressure \< 80 mmHg, with or without amine. Complications will be recorded from induction of general anesthesia to 10 minutes after intubation

Secondary Outcome Measures

Name	Time	Method
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	up to 8 hours	Number of participants with dental breaks
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	up to 28 days	Hospital discharge status (dead/alive)
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	During the general anesthesia, up to 8 hours	Description of intubation (mandrin, videolaryngoscope, videolaryngoscope)

Trial Locations

Locations (13)

CHU de Dijon; 🇫🇷 Dijon, France

CHD Vendée; 🇫🇷 La Roche sur Yon, France

CHRU de Lille - Hôpital Claude Huriez; 🇫🇷 Lille, France

CHU de Rennes; 🇫🇷 Rennes, France

CH de Saint-Nazaire; 🇫🇷 Saint-Nazaire, France

Clinique Mutualiste de l'Estuaire; 🇫🇷 Saint-Nazaire, France

CHU Nantes; 🇫🇷 Nantes, Loire Atlantique, France

CHU Angers; 🇫🇷 Angers, France

CHRU Brest; 🇫🇷 Brest, France

HCL - Hôpital Edouard Herriot; 🇫🇷 Lyon, France

CHU de Nantes - site Laennec; 🇫🇷 Nantes, France

CHU Toulouse; 🇫🇷 Toulouse, France

CH de Valenciennes; 🇫🇷 Valenciennes, France