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

Morbid Obesity Clinical Trial

— VENT OR NOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930678
• Other study ID #: RC22_0359
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2023
• Est. completion date: September 12, 2025

Study information

• Verified date: October 2023
• Source: Nantes University Hospital
• Contact: Mickael VOURC'H, PhD
• Phone: 0244768053
• Email: mickael.vourch[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 702
• Est. completion date: September 12, 2025
• Est. primary completion date: September 12, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid
• Ventilation Therapy; Complications

Intervention

Procedure:
• No ventilation with face mask
During the period of apnea (in general anesthesia), the patient did not help with face mask
• Ventilation with face mask
During the pperiod of apnea (in general anesthesia), the patient did help with face mask

Locations

Country	Name	City	State
France	CHU Angers	Angers
France	CHRU Brest	Brest
France	HCL - Hôpital Edouard Herriot	Lyon
France	CHU de Nantes - site Laennec	Nantes
France	CHU Nantes	Nantes	Loire Atlantique
France	CHU Poitiers	Poitiers
France	CHU Toulouse	Toulouse
France	CHRU Tours	Tours
France	CH de Valenciennes	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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