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临床试验/CTRI/2013/03/003456
CTRI/2013/03/003456已完成不适用

Tracheal intubation through LMA CTRACHâ„¢ with polyvinyl chloride tube: Comparison between two orientations of the tracheal tube during intubation

MANIPAL UNIVERSITY1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年12月9日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
1. The number of attempts taken to intubate with particular orientation of the tracheal tube

研究概览

简要总结

In this patient blinded randomized trial 100 patients aged 18-65 years, belonging to ASA physical status 1 or 2 will be randomized to be tracheally intubated with polyvinyl chloride tube through LMA CAtrach. In group normal orientation the curvature of the tracheal tube will be along the curvature of the LMA Ctrach while in group reverse orientation the curvature of the tracheal tube will be rotated by 180 degree to the intrinsic curvature of LMA Ctrach. The success rate of intubation, first attempt success rates, number of manipulations required during the process of intubation, time for successful intubation, incidence of sore throat and hoarseness of voice will be observed and compared between the two groups.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients of either gender aged between 18- 65 years, belonging to American Society of Anesthesiologists (ASA) physical status 1 and 2, who are scheduled for surgical procedures under general anesthesia requiring tracheal intubation.

排除标准

  • 1.Mouth opening less than 2.5cms 2.Patients with risk of regurgitation and pulmonary aspiration (inadequate fasting, pregnancy, morbid obesity, emergency surgeries requiring rapid sequence induction of anesthesia, history suggestive of acid peptic disease) 3.Oral, maxillofacial or laryngeal pathology where LMA CTrachâ„¢ insertion is contraindicated or difficult.

结局指标

主要结局

1. The number of attempts taken to intubate with particular orientation of the tracheal tube

时间窗: during tracheal intubation with LMA CTrach (one point assessment)

2. First attempt success rate for tracheal intubation with particular orientation of the tracheal tube

时间窗: during tracheal intubation with LMA CTrach (one point assessment)

次要结局

  • The number and type of manipulations of LMA CTrachâ„¢ done to bring the tracheal tube tip and glottis in alignment during intubation(At the time of tracheal intubation)
  • time taken from the beginning of insertion of tracheal tube till obtaining C02 waveform capnography after connecting tracheal tube to ventilator(At the time of tracheal intubation)
  • The presence or absence of sore throat and hoarseness of voice during first 24 hours following surgery(assessed at one point 24 hours following surgery and as reported by the patient at any point of time during these 24 hours)
  • Presence of blood or blood stain on LMA CTrachâ„¢ and tracheal tube after its removal(at the time of removal of LMA and extubation)

研究者

申办方类型
Private medical college

研究点 (1)

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