NCT04246411撤回不适用
Ultrasound-guidance Versus Auscultation to Confirm Optimal Insertion Depth of the Cuffless Oral Ring-Adair-Elwyn (RAE) Endotracheal Tube in Pediatric Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- The proportion of optimal location of the cuffless Oral RAE tube (%)
研究概览
简要总结
The aim of this study is to compare the ultrasound-guidance versus auscultation to confirm optimal insertion depth of the cuffless oral Ring-Adair-Elwyn (RAE) endotracheal tube in pediatric patients undergoing general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children age under 7 years
- •Undergoing general anesthesia
- •Endobronchial intubation with cuffless oral RAE tube
排除标准
- •Pulmonary disease
- •Active upper respiratory tract infection
- •History of upper or lower respiratory tract infection within 2 weeks
- •Emergent operation
- •Unstable vital sign
结局指标
主要结局
The proportion of optimal location of the cuffless Oral RAE tube (%)
时间窗: during operation (until endotracheal extubation) up to 18 hour after induction
The distance between the tip of cuffless RAE tube and right pulmonary artery is within the -5mm \~ +5mm value of the distance between the T2 mid-vertebra and carina (optimal depth)
次要结局
- M-distance (between the carina and the T2 mid-vertebra)(during operation up to 18 hour after induction)
- Distance between the optimal depth and the relocated depth(during operation up to 18 hour after induction)
- Subglottic diameter at the cricoid cartilage level(during operation)
- ID and OD of optimal cuffless oral RAE tube(during operation up to 18 hour after induction)
- Time from intubation to confirming the tube depth(during operation up to 18 hour after induction)
- Distance between the optimal depth and the manufacturer's recommended depth(during operation up to 18 hour after induction)
- Airway leakage pressure(during operation up to 18 hour after induction)
- Incidence of the intraoperative airway-related events(during operation up to 18 hour after induction)
- Incidence of the airway-related symptoms after extubation(up to 18 hour after induction)
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital
研究点 (2)
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