Clinical Trials Directory

Trials / Completed

CompletedNCT06592313

Difficult Airway in the Bariatric Patient: The BARINTUBE Cohort Study

Status
Completed
Phase
Study type
Observational
Enrollment
1,290 (actual)
Sponsor
: Manuel Alberto Guerrero Gutierrez · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2024-10-15
Primary completion
2025-12-16
Completion
2025-12-20
First posted
2024-09-19
Last updated
2026-01-22

Locations

1 site across 1 country: Mexico

Source: ClinicalTrials.gov record NCT06592313. Inclusion in this directory is not an endorsement.