Morbid Obesity, Ventilation Therapy; Complications
Conditions
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)
Interventions
PROCEDURENo ventilation with face mask
During the period of apnea (in general anesthesia), the patient did not help with face mask
PROCEDUREVentilation with face mask
During the pperiod of apnea (in general anesthesia), the patient did help with face mask
Sponsors
Nantes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Morbidly obese patients (BMI greater than or equal to 35).
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORMickael VOURC'H, PhD
Nantes University Hospital
Outcome results
None listed