跳至主要内容
临床试验/NCT01695980
NCT01695980已完成不适用

Laryngeal Mask Airway in Pediatric Adenotonsillectomy

Eastern Virginia Medical School2 个研究点 分布在 1 个国家目标入组 81 人开始时间: 2012年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
81
试验地点
2
主要终点
To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.

研究概览

简要总结

The study will compare how often the tubing kinks when a LMA (laryngeal mask airway) with modified retractor is used compared to use of an endotracheal tube (ETT) and non modified retractor is used.

详细描述

The laryngeal mask airway (LMA)is a device used to secure the airway of patients during general anesthesia. This device is routinely used for anesthesia in elective head and neck surgeries, including adenotonsillectomy. In this study, the efficacy of the LMA will be studied as it pertains to operative times and cost.

The child will be randomized into either the LMA group or the ETT group.

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
None

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • requiring adenotonsillectomy for Obstructive sleep apnea or chronic tonsillitis between the ages of 2-16

排除标准

  • children with BMI >35
  • unwillingness to comply with study procedures
  • children with craniofacial anomalies/abnormalities which will interfere with mask placement
  • children under 2 or over 16

结局指标

主要结局

To determine the number of participants with adverse events with use of LMA and ETT during adenotonsillectomy.

时间窗: one year

Mouth gag equipment is used for the LMA and the ETT. A modified tongue depressor is used with the LMA and a non-modified tongue depressor is used with the ETT. Data will be collected in regards to the rate of kinking/obstruction of the tubing with each type of equipment to determine which option is the best for use in adenotonsillectomy.

次要结局

  • To determine total length of procedure and recovery time with use the LMA.(One year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cristina Baldassari M.D.

Assistant Professor, Pediatric Otolaryngology

Eastern Virginia Medical School

研究点 (2)

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