Clinical trial NCT06592313: Difficult Airway in the Bariatric Patient: the BARINTUBE Cohort Study
Official title: Difficult Airway in the Bariatric Patient: the BARINTUBE Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Bariatric Surgery Candidate
Keywords: bariatric surgery
difficult airway
videolaringoscopy
intubation
airway managment
obesity and anesthesia
preoperative care
Lead sponsor: Instituto Mexicano del Seguro Social
Sponsor class: OTHER_GOV
First posted: 2024-09-19
Enrollment: 1290
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of difficult airway
timeFrame: Day 1
Secondary outcomes:
measure: Incidence of severe hypoxia
timeFrame: Day 1
measure: Incidence of cardiovascular collapse
timeFrame: Day 1
measure: Incidence of minor adverse events
timeFrame: Day 1
measure: Incidence of Difficult Facemask Ventilation
timeFrame: Day 1
measure: Incidence of Difficult or Failed Tracheal Intubation
timeFrame: Day 1
Other outcomes:
measure: Predictors of Difficult Airway
timeFrame: Day 1
measure: Predictors of Difficult or Failed Tracheal Intubation
timeFrame: Day 1
measure: Successful intubation rate according to laryngoscopy method
timeFrame: Day 1
Locations:
city: Tijuana
country: Mexico
facility: Centro Medico Bariatrico
state: Baja California
Study officials:
References: