Difficult Airway in the Bariatric Patient: the BARINTUBE Cohort Study

Last updated: October 25, 2024
Sponsor: : Manuel Alberto Guerrero Gutierrez
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Diabetes Prevention

Treatment

Intubation

Clinical Study ID

NCT06592313
1667/17-05-2024
  • Ages > 18
  • All Genders

Study Summary

Background: Difficult airway in bariatric patients presents significant challenges during anesthesia, impacting patient safety and surgical outcomes. This study aims to estimate the incidence of difficult airway in bariatric patients undergoing surgery.

Materials and Methods: This prospective observational cohort study will be conducted in a single center. Patients over 18 years with a BMI ≥ 30 kg/m2 undergoing bariatric surgery and requiring intubation will be included. Data will be collected on patient demographics, clinical characteristics, and intubation outcomes. The primary outcome is the occurrence of difficult airway, defined by specific criteria including intubation difficulty and the need for alternative airway management techniques. Secondary outcomes include complications related to airway management and overall surgical outcomes. A total of 1290 patients will be included in the study to estimate the incidence of difficult airway within a confidence of 3%.

Conclusions: Difficult airway management in bariatric patients is relatively common and is influenced by specific patient factors. The findings of this study will mainly allow the estimation of difficult airway incidence in patients with bariatric surgery under the new clinical definitions.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients over 18 years of age

  • Patients of both genders

  • Patients diagnosed with BMI greater than or equal to 30 kg/m2

  • Patients who will undergo bariatric surgery

  • Patients who require intubation for intraoperative ariway management

Exclusion

Exclusion Criteria:

  • Patients who withdraw their consent to participate in the study.

Study Design

Total Participants: 1290
Treatment Group(s): 1
Primary Treatment: Intubation
Phase:
Study Start date:
October 15, 2024
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Centro Medico Bariatrico

    Tijuana, Baja California 22046
    Mexico

    Active - Recruiting

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