Difficult Airway in the Bariatric Patient: The BARINTUBE Cohort Study

NCT ID: NCT06592313

Last Updated: 2026-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-15

Study Completion Date

2025-12-20

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Bariatric Surgery Candidate

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing bariatric surgery

Adults with an indication for bariatric surgery who have been schedule for a bariatric surgery procedure.

Intubation

Intervention Type PROCEDURE

Aiway management procedure involving the Insertion of an orotracheal cannula through the oropharynx.

Interventions

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Intubation

Aiway management procedure involving the Insertion of an orotracheal cannula through the oropharynx.

Intervention Type PROCEDURE

Eligibility Criteria

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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 Criteria

* Patients who withdraw their consent to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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: Manuel Alberto Guerrero Gutierrez

OTHER_GOV

Sponsor Role lead

Responsible Party

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: Manuel Alberto Guerrero Gutierrez

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Centro Medico Bariatrico

Tijuana, Estado de Baja California, Mexico

Site Status

Countries

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Mexico

Other Identifiers

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1667/17-05-2024

Identifier Type: -

Identifier Source: org_study_id

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