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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.
Anesthesia consultation or pre-anesthesia visit:
D0 (day of inclusion):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without ventilation | Active Comparator | No ventilation sequence during the intubation period and without face mask ventilation during the apnea period |
|
| With ventilation | Experimental | Sequence "with ventilation" during the apnea period with face mask ventilation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No ventilation with face mask | Procedure | During the period of apnea (in general anesthesia), the patient did not help with face mask |
|
| 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 |
| 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 |
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Inclusion criteria:
Non-inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mickael VOURC'H, PhD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes | Nantes | Loire Atlantique | 44100 | France | ||
| CHU Angers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41219812 | Derived | Znaidi S, Deransy R, Asehnoune K, Le Penndu M, Rozec B, Jumel G, Lasocki S, Cadic-Pelletier A, Guinot PG, Duchalais A, Cirenei C, Abrard S, Beloeil H, Fortuit C, Landrin J, Porta Bonete G, Defrancq F, Pere M, Vourc'h M. Intubation of obese patients in the operating room with or without bag-mask ventilation: study protocol for a randomized multicenter trial (VENT OR NOT). Trials. 2025 Nov 11;26(1):492. doi: 10.1186/s13063-025-09114-z. |
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Morbidly obese patients (BMI greater than or equal to 35).
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| Ventilation with face mask | Procedure | During the pperiod of apnea (in general anesthesia), the patient did help with 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 |
| Angers |
| 49933 |
| France |
| CHRU Brest | Brest | 29609 | France |
| CHU de Dijon | Dijon | 21000 | France |
| CHD Vendée | La Roche-sur-Yon | 85925 | France |
| CHRU de Lille - Hôpital Claude Huriez | Lille | 59037 | France |
| HCL - Hôpital Edouard Herriot | Lyon | France |
| CHU de Nantes - site Laennec | Nantes | France |
| CHU de Rennes | Rennes | 35033 | France |
| CH de Saint-Nazaire | Saint-Nazaire | 44600 | France |
| Clinique Mutualiste de l'Estuaire | Saint-Nazaire | 44600 | France |
| CHU Toulouse | Toulouse | 31300 | France |
| CH de Valenciennes | Valenciennes | France |
| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008397 | Masks |
| D014691 | Ventilation |
| ID | Term |
|---|---|
| D058257 | Surgical Attire |
| D004865 | Equipment and Supplies, Hospital |
| D004864 | Equipment and Supplies |
| D011482 | Protective Devices |
| D000067393 | Personal Protective Equipment |
| D013523 | Surgical Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D004780 | Environment, Controlled |
| D004777 | Environment |
| D004778 | Environment and Public Health |
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