NCT03996343撤回不适用
Laryngeal Mask Airway Versus Endotracheal Intubation for Airway Management During General Anesthesia in Obese Children
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Severe respiratory adverse events
研究概览
简要总结
The investigators in this study want to see how overweight/obese children who undergo elective surgery requiring airway management react to general anesthesia. They believe that the incidence of perioperative respiratory adverse events (PRAE) associated with Laryngeal mask airway (LMA) use during general anesthesia in overweight/obese children is lower than that associated with endotracheal intubation (ETT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •sex-specific body mass index (BMI) is ≥85th percentile
- •elective surgical outpatient peripheral or lower abdominal procedures
- •Surgery length estimated to last between 30 and 120 minutes
排除标准
- •Active gastro-esophageal reflux, possible difficult intubation or planned asleep fiber optic intubation, cardiac disease, thoracic deformities, upper abdominal, and thoracic or airway surgeries.
- •Children with active asthmatic attack or those considered to be "full stomach" will also be excluded.
- •Laparoscopic surgical procedures and those requiring extreme head-down tilt will also be excluded.
- •Children with a physiology or other condition requiring a certain type of airway for the procedure will also be excluded
- •Children whose anesthesiologist is not agreeable to randomization of airway management choice will also be excluded.
研究组 & 干预措施
Laryngeal mask airway
Experimental
干预措施: Laryngeal mask airway (Device)
Endotracheal intubation
Experimental
干预措施: Endotracheal intubation (Device)
结局指标
主要结局
Severe respiratory adverse events
时间窗: perioperative period
laryngospasm, bronchospasm
次要结局
未报告次要终点
研究者
Olubukola Nafiu
Associate Professor of Anesthesiology
University of Michigan
研究点 (2)
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