Difficult Airway in the Bariatric Patient: The BARINTUBE Cohort Study

NCT06592313 | Completed

• 1 other identifier: 1667/17-05-2024
• Study Type: observational
• Target: 1,290
• Locations: 1 country
• Sites: 1

Brief 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

Obesity; Bariatric Surgery Candidate

Keywords

bariatric surgery; difficult airway; videolaringoscopy; intubation; airway managment; obesity and anesthesia; preoperative care

Outcome Measures

Primary Outcomes (1)

• Incidence of difficult airway

  Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of difficult airway (anticipated or unanticipated difficulty or failure is experienced by a physician trained in anesthesia care, including but not limited to one or more of the following: facemask ventilation, laryngoscopy, ventilation using a supraglottic airway, tracheal intubation, extubation, or invasive airway).

  Day 1

Secondary Outcomes (5)

• Incidence of severe hypoxia

  Day 1

• Incidence of cardiovascular collapse

  Day 1

• Incidence of minor adverse events

  Day 1

• Incidence of Difficult Facemask Ventilation

  Day 1

• Incidence of Difficult or Failed Tracheal Intubation

  Day 1

Other Outcomes (3)

• Predictors of Difficult Airway

  Day 1

• Predictors of Difficult or Failed Tracheal Intubation

  Day 1

• Successful intubation rate according to laryngoscopy method

  Day 1

Study Arms (1)

Patients undergoing bariatric surgery

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

Procedure: Intubation

Interventions

Intubation PROCEDURE

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

Patients undergoing bariatric surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a body mass index greater than or equal to 30 kg/m2 scheduled for bariatric surgery.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• : Manuel Alberto Guerrero Gutierrez: lead

Study Sites (1)

Centro Medico Bariatrico

Tijuana, Estado de Baja California, 22046, Mexico

Location

MeSH Terms

Conditions

Obesity

Interventions

Intubation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: October 15, 2024
• Primary Completion: December 16, 2025
• Study Completion: December 20, 2025
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting information will be made available with the final original research article, which will be made available as a preprint within a maximum 1-year term after the study conclusion date. This report will be subsequently sent for publication in a peer-reviewed journal. Other pre-specified outcomes may be reported in separate publication after the main research article, reason why the indicated time frame does not apply for such outcomes. There is not an anticipated end term for access to the data and supporting information, as these will be deposited in data and code repository sites as priorly indicated.
• Access Criteria: No data and supporting information access restrictions are anticipated, as these will be deposited in open access repositories (i.e., Harvard Dataverse, Open Science Framework, Zenodo).

Locations

ME (1)