Difficult Airway in the Bariatric Patient: The BARINTUBE Cohort Study (BARINTUBE)

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Intubation

• Study Type: Observational
• Enrollment (Actual): 1290

Contacts and Locations

Study Locations

• Mexico
  • Estado de Baja California
    • Tijuana, Estado de Baja California, Mexico, 22046
      • Centro Medico Bariatrico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing bariatric surgery; Adults with an indication for bariatric surgery who have been schedule for a bariatric surgery procedure.	Procedure: Intubation; Aiway management procedure involving the Insertion of an orotracheal cannula through the oropharynx.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of severe hypoxia	Cumulative incidence (expressed as percentage) of severe hypoxia, defined as a peripheral blood oxygen saturation (SpO2) lower than 80% during advanced airway management.	Day 1
Incidence of cardiovascular collapse	Cumulative incidence (expressed as percentage) of cardiovascular collapse, defined as any of the following events within 30 minutes from induction to surgical incision: Systolic blood pressure lower than 65 mmHg.; Dyastolic blood pressure ower than 90 mmHg for more than 15 minutes; Unplanned need for vasopressors or fluid loading greater than; 15 ml/kg to maintain target blood pressure.	Day 1
Incidence of minor adverse events	Cumulative incidence (expressed as percentage) of minor adverse events, including: Moderate hypoxia (SpO2 lower than 93%),; Airway injury,; Clinically relevant bleeding,; Oral aspiration of gastric contents,; Dental injury,; Lip injury.	Day 1
Incidence of Difficult Facemask Ventilation	Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of Difficult Facemask Ventilation (It is not possible to provide adequate ventilation, because of one or more of the following problems: inadequate mask seal, excessive gas leak, or excessive resistance to the ingress or egress of gas.). For operationalization, successful face mask ventilation with 2 hands will be consigned as the reference (No difficult face mask ventilation), whereas face mask ventilation attempts with 4 or 6 hands will be considered as the presence of difficult face mask ventilation.	Day 1
Incidence of Difficult or Failed Tracheal Intubation	Cumulative incidence (expressed as a percentage), according to the American Society of Anesthesiologists 2022 definition of Difficult or Failed Tracheal Intubation (Tracheal intubation requires multiple attempts or tracheal intubation fails after multiple attempts.). For operationalization, more than 1 attempt will be considered as Difficult or Failed Tracheal Intubation.	Day 1

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictors of Difficult Airway	Predictors of difficult airway will be identified through a multivariable generalized linear regression model.	Day 1
Predictors of Difficult or Failed Tracheal Intubation	Predictors of greater number of intubation attempts will be identified through a multivariable generalized linear regression model.	Day 1
Successful intubation rate according to laryngoscopy method	Participants will be grouped according to the laryngoscopy method (direct laryngoscopy vs videolaryngoscopy) and the cumulative incidence of successful intubation (expressed as proportion) will be calculated for each group. The risk difference and an appropriate measure of association (i.e., risk ratio, odds ratio) will be estimated.	Day 1

Collaborators and Investigators

• Sponsor: : Manuel Alberto Guerrero Gutierrez

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2024
• Primary Completion (Actual): December 16, 2025
• Study Completion (Actual): December 20, 2025

Study Registration Dates

• First Submitted: September 9, 2024
• First Submitted That Met QC Criteria: September 9, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2026
• Last Update Submitted That Met QC Criteria: January 20, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: bariatric surgery; intubation; difficult airway; preoperative care; videolaringoscopy; airway managment; obesity and anesthesia
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Investigative Techniques; Therapeutics; Intubation
• Other Study ID Numbers: 1667/17-05-2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data will be deposited and made available through an open acess data repository (i.e., Harvard Dataverse). Any potentially sensitive patient-identifying data will either not be released or will undergo minimization and aggregation/abstraction procedures to reduce participant identification risk. Informed consent forms will indicate that a minimal risk of re-identification cannot be excluded despite all these participant data protection methods,in compliance with current IPD sharing recommendations.
• IPD Sharing 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.
• IPD Sharing 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).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No