VENT OR NOT: Intubation of Obese Patients in the Operating Room With or Without Bag-Mask Ventilation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Anesthesia consultation or pre-anesthesia visit:
-
screening for inclusion and non-inclusion criteria
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patient information
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collection of consent
-
inclusion
D0 (day of inclusion):
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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)
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general anesthesia : intubation according to randomization arm + collection primary endpoint + conduct of the intubation procedure + morbidity of the intubation procedure
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after general anesthesia : collection of secondary endpoints + conduct of the intubation procedure + morbidity of the intubation procedure + intraoperative respiratory morbidity
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post-interventional care room : collection of clinical parameters in the ICU : postoperative morbidity + study discharge (hospital discharge)
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Without ventilation No ventilation sequence during the intubation period and without face mask ventilation during the apnea period |
Procedure: No ventilation with face mask
During the period of apnea (in general anesthesia), the patient did not help with face mask
|
| Experimental: With ventilation Sequence "with ventilation" during the apnea period with face mask ventilation |
Procedure: Ventilation with face mask
During the pperiod of apnea (in general anesthesia), the patient did help with face mask
|
Outcome Measures
Primary Outcome Measures
- 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
- 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]
Difficulty with mask ventilation (yes/no)
- 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 10 minutes]
Measure of the saturation before the first laryngoscopy with oximeter
- 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 10 minutes]
Measure of the lowest saturation during the intubation procedure and the following 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 [During the general anesthesia, up to 8 hours]
Quality of exposure under laryngoscopy (position of the patient)
- 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]
Difficulties in intubation (yes/no)
- 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)
- 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]
Rate of desaturation <80% (yes/no)
- 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]
Rate of desaturation <90% (yes/no)
- 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]
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)
- 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 cardiac arrest
- 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]
Death during intubation
- 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]
Difficulties in intubations (yes/no) with the number of intubation attempts
- 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 cardiac rhythm disorders
- 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 esophageal intubations
- 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 regurgitation/inhalation
- 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 [5 minutes, 30 minutes and 1 hour after intubation]
Need for FiO2 >50% during surgery to achieve >95% saturation (yes/no)
- 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]
Length of stay in the post-operation monitoring room
- 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]
Duration of postoperative mechanical ventilation(in minutes)
- 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]
Number of participants with nausea
- 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]
Number of participants with vomiting
- 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]
Length of hospitalization since randomization
- 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)
Eligibility Criteria
Criteria
Inclusion criteria:
-
patient requiring general anesthesia with intubation for surgery or scheduled endoscopic procedures
-
age > 18 years
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with a BMI superior or equal to 35kg.m-²
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patient having signed an informed consent
Non-inclusion criteria:
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ambient air saturation <90%
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urgent surgery < 24 hours
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cardio-thoracic surgery
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mask ventilation not possible (e.g. ATCD, cervical irradiation, fixed mandible)
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formal contraindication to mask ventilation (e.g. occlusive syndrome, non fasting patient, symptomatic gastroesophageal reflux untreated or persistent under treatment)
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wish of the operator for high flow oxygen preoxygenation
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wish of an intubation without curare by the operator
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pregnant or breast-feeding women
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protected adults (guardianship, curatorship or safeguard of justice)
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participation in another randomized clinical research study concerning preoxygenation and relevant to the primary endpoint
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absence of affiliation to the French social security system
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU Nantes | Nantes | Loire Atlantique | France | 44100 |
| 2 | CHU Angers | Angers | France | 49933 | |
| 3 | CHRU Brest | Brest | France | 29609 | |
| 4 | HCL - Hôpital Edouard Herriot | Lyon | France | ||
| 5 | CHU Poitiers | Poitiers | France | 86021 | |
| 6 | CHU Toulouse | Toulouse | France | 31300 | |
| 7 | CHRU Tours | Tours | France | 37000 | |
| 8 | CH de Valenciennes | Valenciennes | France |
Sponsors and Collaborators
- Nantes University Hospital
Investigators
- Principal Investigator: Mickael VOURC'H, PhD, CHU de Nantes
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC22_0359