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

Last updated: November 22, 2024
Sponsor: Nantes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Treatment

Ventilation with face mask

No ventilation with face mask

Clinical Study ID

NCT05930678
RC22_0359
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 Design

Total Participants: 702
Treatment Group(s): 2
Primary Treatment: Ventilation with face mask
Phase:
Study Start date:
September 12, 2023
Estimated Completion Date:
September 12, 2025

Study 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)

Connect with a study center

  • CHU Nantes

    Nantes, Loire Atlantique 44100
    France

    Active - Recruiting

  • CHU Angers

    Angers, 49933
    France

    Active - Recruiting

  • CHRU Brest

    Brest, 29609
    France

    Active - Recruiting

  • CHU de Dijon

    Dijon, 21000
    France

    Active - Recruiting

  • CHD Vendée

    La Roche sur Yon, 85925
    France

    Active - Recruiting

  • CHRU de Lille - Hôpital Claude Huriez

    Lille, 59037
    France

    Active - Recruiting

  • HCL - Hôpital Edouard Herriot

    Lyon,
    France

    Active - Recruiting

  • CHU de Nantes - site Laennec

    Nantes,
    France

    Active - Recruiting

  • CHU Poitiers

    Poitiers, 86021
    France

    Site Not Available

  • CHU de Rennes

    Rennes, 35033
    France

    Active - Recruiting

  • CH de Saint-Nazaire

    Saint-Nazaire, 44600
    France

    Active - Recruiting

  • Clinique Mutualiste de l'Estuaire

    Saint-Nazaire, 44600
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse, 31300
    France

    Active - Recruiting

  • CHRU Tours

    Tours, 37000
    France

    Site Not Available

  • CH de Valenciennes

    Valenciennes,
    France

    Active - Recruiting

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