Difficult Airway in the Bariatric Patient: The BARINTUBE Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,290
- 试验地点
- 1
- 主要终点
- Incidence of difficult airway
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients who withdraw their consent to participate in the study.
结局指标
主要结局
Incidence of difficult airway
时间窗: 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).
次要结局
- 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)
研究者
: Manuel Alberto Guerrero Gutierrez
Principal Investigator
Instituto Mexicano del Seguro Social