Intubation of Obese Patients in the Operating Room With or Without Face Mask Ventilation (VENT OR NOT)

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

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.

Study Overview

• Status: Completed
• Conditions: Morbid Obesity; Ventilation Therapy; Complications
• Intervention / Treatment: Procedure: No ventilation with face mask; Procedure: Ventilation with face mask

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)

• Study Type: Interventional
• Enrollment (Actual): 725
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Angers, France, 49933
    • Chu Angers
  • Brest, France, 29609
    • CHRU Brest
  • Dijon, France, 21000
    • CHU de Dijon
  • La Roche-sur-Yon, France, 85925
    • CHD Vendee
  • Lille, France, 59037
    • CHRU de Lille - Hopital Claude Huriez
  • Lyon, France
    • HCL - Hôpital Edouard Herriot
  • Nantes, France
    • CHU de Nantes - site Laennec
  • Rennes, France, 35033
    • CHU de Rennes
  • Saint-Nazaire, France, 44600
    • CH de Saint-Nazaire
  • Saint-Nazaire, France, 44600
    • Clinique Mutualiste de l'Estuaire
  • Toulouse, France, 31300
    • Chu Toulouse
  • Valenciennes, France
    • Ch de Valenciennes
  • Loire Atlantique
    • Nantes, Loire Atlantique, France, 44100
      • Chu Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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	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
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

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Mickael VOURC'H, PhD, Nantes University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2023
• Primary Completion (Actual): June 24, 2025
• Study Completion (Actual): July 3, 2025

Study Registration Dates

• First Submitted: June 1, 2023
• First Submitted That Met QC Criteria: June 30, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity, Morbid; Environment and Public Health; Surgical Equipment; Equipment and Supplies; Manufactured Materials; Technology, Industry, and Agriculture; Environment; Environment, Controlled; Protective Devices; Personal Protective Equipment; Surgical Attire; Equipment and Supplies, Hospital; Masks; Ventilation
• Other Study ID Numbers: RC22_0359

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No