Difficult Airway in the Bariatric Patient: the BARINTUBE Cohort Study

Recruiting

• Conditions: Obesity; Bariatric Surgery Candidate
• Interventions: Procedure: Intubation

• Registration Number: NCT06592313
• Lead Sponsor: : Manuel Alberto Guerrero Gutierrez

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-09
• Study First Submitted QC: 2024-09-09
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Study Start: 2024-10-15
• Last Update Submitted: 2024-10-25
• Last Update Posted: 2024-10-29
• Primary Completion: 2025-10-31
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1290

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing bariatric surgery	Intubation	Adults with an indication for bariatric surgery who have been schedule for a bariatric surgery procedure.

Primary Outcome Measures

Name	Time	Method
Incidence of difficult airway	Day 1	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).

Secondary Outcome Measures

Name	Time	Method
Incidence of severe hypoxia	Day 1	Cumulative incidence (expressed as percentage) of severe hypoxia, defined as a peripheral blood oxygen saturation (SpO2) lower than 80% during advanced airway management.
Incidence of cardiovascular collapse	Day 1	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.
Incidence of minor adverse events	Day 1	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.
Incidence of Difficult Facemask Ventilation	Day 1	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.
Incidence of Difficult or Failed Tracheal Intubation	Day 1	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.

Trial Locations

Locations (1)

Centro Medico Bariatrico; 🇲🇽 Tijuana, Baja California, Mexico