跳至主要内容
临床试验/CTRI/2017/12/010782
CTRI/2017/12/010782尚未招募1/2 期

To evaluate a novel airway device, Gnana Laryngeal Airway in clinical practice: A pilot study.

Director Principal1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2017年12月15日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Ease of insertion grade of Gnana laryngeal airway device.

研究概览

简要总结

Laryngeal mask airway (LMA) devices are presently use worldwide by anaesthesiologist for airway management in adults and children’s and is considered a novel route to provide general anaesthesia. There are currently seven versions of the LMA’s available, which are LMA-Classic, LMA-Unique, LMA-Fastrach, LMA-ProSeal, LMA-Supreme, LMA-Ambu and LMA-Soft Seal. Recently, a laryngeal airway device was designed as a latest version of LMA called Gnana laryngeal airway. It consists of an elliptical cuffed mask and an airway tube. The concave portion of the mask when inflated faces the vocal cords. With the aim of keeping the area around the laryngeal mask clean of secretions, an inbuilt small suction port has been added into convex part of the laryngeal mask airway. there are numerous clinical studies involving the use of various version of LMAs, attesting to their safety and performance in various clinical situations. It is hypothesised that the Gnana laryngeal airway might reduce the possible airway complication by incorporation of suction port on its convex surface. At present there are limited trials done on the Gnana laryngeal airway. The purpose of this study is to evaluate Gnana laryngeal airway in terms of success rate, ease and speed of insertion, performance during general anaesthesia (oropharyngeal leak pressure (OLP) measurement after insertion of device by documented method and exact placement of device seen by flexible fiberoptic view of larynx) and rate of complications in patients requiring anaesthesia for various surgical procedures.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.American Society of Anesthesiologist (ASA) physical status 1 and 2 of either sex 2.Age group: 18-60 years 3.Body Mass Index (BMI): <30 kg/ m2 4.Scheduled for elective surgeries with duration <2 hours and requiring general anaesthesia with controlled ventilation 5.No concurrent participation in another study.

排除标准

  • 1.Patients’ refusal or inability to give informed consent 2.American Society of Anesthesiologist (ASA) ≥3 physical status of either sex 3.Emergency surgical procedures 4.Upper respiratory tract infection 5.Anticipated difficult airway 6.Patients at increased risk of aspiration -gastro esophageal reflux disease, non fasting status, pregnancy 7.Cardiorespiratory or cerebrovascular disease 8.Diabetes Mellitus.

结局指标

主要结局

Ease of insertion grade of Gnana laryngeal airway device.

时间窗: Immediately Post-induction of general anaesthesia. [Single time point]

次要结局

  • 1.Time taken for Gnana laryngeal airway device insertion.(2. Oropharyngeal Leak Pressure of Gnana airway device.)

研究者

申办方类型
Government medical college

研究点 (1)

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