The Use of a Second-Generation Laryngeal Mask Airway Versus Endotracheal Tube in Obese Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- Proportion of Participants With Postoperative Hypoxia
研究概览
简要总结
This prospective, randomized, comparative study is intended to enroll a total of 148 patients with a BMI 30-49.9 kg/m2 undergoing surgery at Parkland Hospital. The efficacy and performance of a second-generation LMA will be compared to endotracheal intubation. A standardized anesthetic protocol that is usual and customary for the type of operation the patient is having will be provided to the anesthesia teams of enrolled subjects. The remainder of the anesthetic care of the subject will not deviate from the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-80 years old
- •Obese (BMI > or equal to 30 kg/m2
- •Scheduled for a non-emergent surgery that requires general anesthesia (e.g., orthopedic, breast, urological, colorectal, ENT, vascular, general surgery)
- •Willing and able to consent in English or Spanish
- •No current history of advanced pulmonary or cardiac disease
排除标准
- •Age less than 18 or older than 80
- •BMI ≥50 or < 30 kg/m2
- •Patient does not speak English or Spanish
- •Expected surgical duration longer than 4 hours
- •Planned postoperative ICU admission
- •Patient refusal
- •Monitored anesthesia care (MAC) or regional anesthesia planned
- •Pregnant or nursing women
- •"Stat" (emergent) cases
- •Known or suspected difficult airway
- •Full stomach/significant aspiration risk (gastroparesis, emergency surgery, untreated moderate to severe gastroesophageal reflux disease, hiatal hernia)
- •No history of gastric surgery
- •Surgery in position other than supine (e.g., Trendelenburg)
- •Laparoscopic surgery
结局指标
主要结局
Proportion of Participants With Postoperative Hypoxia
时间窗: Up to 80 minutes post-operatively
Patients in the 2 groups will be assessed for postoperative hypoxia (1 or more episodes) in the PACU using a visual analog scale.
次要结局
- Alterations in Blood Pressure(Intra-operatively)
- Alterations in Heart Rate(Intra-operatively)
- Alterations in Oxygen Saturation (at Baseline)(Baseline)
- Alterations in Oxygen Saturation (at T15)(at 15 mins postoperatively)
- Alterations in Oxygen Saturation (at T45)(at 45 mins postoperatively)
- Alterations in Oxygen Saturation (at T80)(at 80 mins postoperatively)
- Alterations in Respiratory Rate(Baseline)
研究者
Tiffany B Moon
Associate Professor
University of Texas Southwestern Medical Center