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Completed

NCT Number: NCT06592313

Difficult Airway in the Bariatric Patient: The BARINTUBE Cohort Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centro Medico Bariatrico

Tijuana, Estado de Baja California, 22046, Mexico

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intubation

Procedure

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

Primary outcomes

  1. Incidence of difficult airway

    Time frame: 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 outcomes

  1. Incidence of severe hypoxia

    Time frame: 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.

  2. Incidence of cardiovascular collapse

    Time frame: 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.
  3. Incidence of minor adverse events

    Time frame: 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.
  4. Incidence of Difficult Facemask Ventilation

    Time frame: 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.

  5. Incidence of Difficult or Failed Tracheal Intubation

    Time frame: 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.

Other outcomes

  1. Predictors of Difficult Airway

    Time frame: Day 1

    Predictors of difficult airway will be identified through a multivariable generalized linear regression model.

  2. Predictors of Difficult or Failed Tracheal Intubation

    Time frame: Day 1

    Predictors of greater number of intubation attempts will be identified through a multivariable generalized linear regression model.

  3. Successful intubation rate according to laryngoscopy method

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

: Manuel Alberto Guerrero Gutierrez

Other Gov

Registry information

Acronym: BARINTUBE

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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