跳至主要内容
临床试验/CTRI/2023/06/053354
CTRI/2023/06/053354尚未招募不适用

"A study to assess Supraglottic Airway Device guided endotracheal tube placement using Ambu Aura 40 versus Ambu Aura i"

Pt BD Sharma PGIMS Rohtak1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年10月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the ease and success of endotracheal tube placement through ambu aura 40 versus.ambu aura i. maximum of 3 attempts. expected to be within 30 seconds

研究概览

简要总结

This prospective ,randomised , single  blinded study will be conducted in the Department of Anaesthesiology and Critical Care,Pt.B.D.Sharma PGIMS,Rohtak . Sixty patients of either sex aged 18 to 60 years belonging to ASA Grade 1 and 2 undergoing surgical procedures requiring intubation will be included in this study.All the patients will be examined pre operatively and details of the clinical history ,general physical examination and systemic examination will be recorded . Detailed examination of the patients will be carried out for any neck mass ,any loose tooth,mouth opening .Routine investigations like hemoglobin,bleeding time,clotting time and complete urine examination will be carried out in all the patients .Any other relevant investigation like blood urea ,srum creatinine ,serum electrolytes, chest x-ray and ECG will be done as and when required.Patient will be explained about the procedure and written and informed consent will be obtained for participation in the study.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Participant Blinded

入排标准

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

入选标准

  • Sixty adult patients aged between 18-60 years of either sex of ASA grade I and II scheduled for elective surgery requiring general anaesthesia will be included.

排除标准

  • patients refusing to participate,having respiratory or pharyngeal pathology,mouth opening <2.5 cms ,body mass index>30kgm² ,pregnancy,full stomach,suspected difficult airway will be excluded.

结局指标

主要结局

To compare the ease and success of endotracheal tube placement through ambu aura 40 versus.ambu aura i. maximum of 3 attempts. expected to be within 30 seconds

时间窗: time for insertion of device(within 10 sec), Time for insertion of tube (within 20 sec), Hemodynamic parameters at Baseline, At time of induction, at supraglottic insertion, At Tube insertion, after 5 min

次要结局

  • Time taken for placement of SAD and intubation through SAD(Position of SAD confirmed with Fiberoptic)

研究者

发起方
Pt BD Sharma PGIMS Rohtak
申办方类型
Government medical college

研究点 (1)

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