临床试验/NCT01320163

NCT01320163已完成不适用

Clinical Acceptability of I-GEL® in Pediatric Patients: Comparison of Clinical Performance With Classic-LMA™

Seoul National University Hospital2 个研究点分布在 2 个国家目标入组 108 人开始时间: 2011年2月最近更新: 2012年5月30日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: Seoul National University Hospital
入组人数: 108
试验地点: 2
主要终点: airway leak pressure

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study is designed to determine whether a functional difference exists between the laryngeal mask airway (LMA)-Classic™ and i-gel in anesthetized children who have received neuromuscular blockade.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Single (Outcomes Assessor)

入排标准

年龄范围: 1 Year 至 9 Years（Child）
性别: All
接受健康志愿者: 否

入选标准

•ASA I-II, Mallampati I or II, presenting for elective surgery who require general anesthesia in whom tracheal intubation is not necessary

排除标准

•Patients will be excluded from the study if they present as Mallampati III or IV, ASA III-V or emergency status
•upper airway abnormality

结局指标

主要结局

airway leak pressure

时间窗: within 5 min of insertion of each device

Airway leak pressure was determined by adjusting the expiratory valve of the breathing circle to 40 cmH2O (fixed fresh gas flow 3 L/min) and recording the pressure when equilibrium was reached.

次要结局

未报告次要终点

研究者

发起方

Seoul National University Hospital

申办方类型

Other

责任方

Principal Investigator

主要研究者

Jin-Tae Kim

assisstant professor

Seoul National University Hospital

研究点 (2)

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