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: * 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
725
During the period of apnea (in general anesthesia), the patient did not help with face mask
During the pperiod of apnea (in general anesthesia), the patient did help with face mask
CHU Nantes
Nantes, Loire Atlantique, France
CHU Angers
Angers, France
CHRU Brest
Brest, France
CHU de Dijon
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
Time frame: From induction of general anesthesia to 10 minutes after intubation
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)
Time frame: 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
Time frame: 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
Time frame: 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)
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Dijon, France
CHD Vendée
La Roche-sur-Yon, France
CHRU de Lille - Hôpital Claude Huriez
Lille, France
HCL - Hôpital Edouard Herriot
Lyon, France
CHU de Nantes - site Laennec
Nantes, France
CHU de Rennes
Rennes, France
CH de Saint-Nazaire
Saint-Nazaire, France
...and 3 more locations
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: up to 28 days