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

Study Overview
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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.

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)

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

Conditions
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Morbid Obesity, Ventilation Therapy; Complications

Intervention / Treatment
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* Procedure: No ventilation with face mask
* Procedure: Ventilation with face mask


Participation Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Morbidly obese patients (BMI greater than or equal to 35).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Without ventilation<br>No ventilation sequence during the intubation period and without face mask ventilation during the apnea period | Procedure: No ventilation with face mask<br>* During the period of apnea (in general anesthesia), the patient did not help with face mask<br>|
| Experimental: With ventilation<br>Sequence with ventilation during the apnea period with face mask ventilation | Procedure: Ventilation with face mask<br>* During the pperiod of apnea (in general anesthesia), the patient did help with face mask<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | From induction of general anesthesia to 10 minutes after intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Difficulty with mask ventilation (yes/no) | During the general anesthesia, up to 8 hours | 
| 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 | Measure of the saturation before the first laryngoscopy with oximeter | During the general anesthesia, up to 10 minutes | 
| 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 | Measure of the lowest saturation during the intubation procedure and the following 10 minutes | During the general anesthesia, up to 10 minutes | 
| 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 | Quality of exposure under laryngoscopy (position of the patient) | During the general anesthesia, up to 8 hours | 
| 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 | Difficulties in intubation (yes/no) | During the general anesthesia, up to 8 hours | 
| 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 | Description of intubation (mandrin, videolaryngoscope, videolaryngoscope) | During the general anesthesia, up to 8 hours | 
| 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 | Rate of desaturation <80% (yes/no) | up to 8 hours | 
| 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 | Rate of desaturation <90% (yes/no) | up to 8 hours | 
| 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 | Presence of severe hypotension during intubation and in the following hour defined by a systolic blood pressure < 80 mmHg, with or without amine (yes/no) | up to 8 hours | 
| 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 | Number of participants with cardiac arrest | up to 8 hours | 
| 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 | Death during intubation | up to 8 hours | 
| 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 | Difficulties in intubations (yes/no) with the number of intubation attempts | up to 8 hours | 
| 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 | Number of participants with cardiac rhythm disorders | up to 8 hours | 
| 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 | Number of participants with esophageal intubations | up to 8 hours | 
| 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 | Number of participants with regurgitation/inhalation | up to 8 hours | 
| 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 | Number of participants with dental breaks | up to 8 hours | 
| 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 | Need for FiO2 >50% during surgery to achieve >95% saturation (yes/no) | 5 minutes, 30 minutes and 1 hour after intubation | 
| 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 | Length of stay in the post-operation monitoring room | up to 28 days | 
| 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 | Duration of postoperative mechanical ventilation(in minutes) | up to 28 days | 
| 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 | Number of participants with nausea | up to 28 days | 
| 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 | Number of participants with vomiting | up to 28 days | 
| 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 | Length of hospitalization since randomization | up to 28 days | 
| 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 | Hospital discharge status (dead/alive) | up to 28 days |