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Completed

NCT Number: NCT05930678

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

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.

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Key information

Conditions

Morbid Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Ventilation Therapy; Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nantes, Nantes, Loire Atlantique, France

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About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No ventilation with face mask

Procedure

During the period of apnea (in general anesthesia), the patient did not help with face mask

Ventilation with face mask

Procedure

During the pperiod of apnea (in general anesthesia), the patient did help with face mask

Primary outcomes

  1. 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

    Time frame: 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 outcomes

  1. 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

    Time frame: During the general anesthesia, up to 8 hours

    Difficulty with mask ventilation (yes/no)

  2. 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

    Time frame: During the general anesthesia, up to 10 minutes

    Measure of the saturation before the first laryngoscopy with oximeter

  3. 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

    Time frame: During the general anesthesia, up to 10 minutes

    Measure of the lowest saturation during the intubation procedure and the following 10 minutes

  4. 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

    Time frame: During the general anesthesia, up to 8 hours

    Quality of exposure under laryngoscopy (position of the patient)

  5. 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

    Time frame: During the general anesthesia, up to 8 hours

    Difficulties in intubation (yes/no)

  6. 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

    Time frame: During the general anesthesia, up to 8 hours

    Description of intubation (mandrin, videolaryngoscope, videolaryngoscope)

  7. 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

    Time frame: up to 8 hours

    Rate of desaturation <80% (yes/no)

  8. 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

    Time frame: up to 8 hours

    Rate of desaturation <90% (yes/no)

  9. 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

    Time frame: 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)

  10. 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

    Time frame: up to 8 hours

    Number of participants with cardiac arrest

  11. 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

    Time frame: up to 8 hours

    Death during intubation

  12. 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

    Time frame: up to 8 hours

    Difficulties in intubations (yes/no) with the number of intubation attempts

  13. 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

    Time frame: up to 8 hours

    Number of participants with cardiac rhythm disorders

  14. 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

    Time frame: up to 8 hours

    Number of participants with esophageal intubations

  15. 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

    Time frame: up to 8 hours

    Number of participants with regurgitation/inhalation

  16. 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

    Time frame: up to 8 hours

    Number of participants with dental breaks

  17. 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

    Time frame: 5 minutes, 30 minutes and 1 hour after intubation

    Need for FiO2 >50% during surgery to achieve >95% saturation (yes/no)

  18. 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

    Time frame: up to 28 days

    Length of stay in the post-operation monitoring room

  19. 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

    Time frame: up to 28 days

    Duration of postoperative mechanical ventilation(in minutes)

  20. 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

    Time frame: up to 28 days

    Number of participants with nausea

  21. 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

    Time frame: up to 28 days

    Number of participants with vomiting

  22. 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

    Time frame: up to 28 days

    Length of hospitalization since randomization

  23. 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

    Time frame: up to 28 days

    Hospital discharge status (dead/alive)

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: VENT OR NOT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 5, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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