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临床试验/CTRI/2019/06/019782
CTRI/2019/06/019782已完成4 期

A study to compare Air Q with Intubating Laryngeal Mask Airway as intubation conduit in patients with simulated fixed cervical spine

Department of Anaesthesiology and Critical Care1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2019年6月24日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
88
试验地点
1
主要终点
1. Success rate of intubation.

研究概览

简要总结

The  aim and objectives of the thesis is to evaluate and compare endotracheal intubation through two supraglottic airway devices, Air Q Intubating Laryngeal Airway and Intubating Laryngeal Mask Airway as intubation conduit in patients with simulated fixed cervical spine.  Adult patient, 18 to 60 years of age of either sex, ASA physical status I and II, scheduled for elective surgery under general anaesthesia requiring intubation. Total of 88 patients, 44 in each group will be studied. The success rate of intubation in both the groups, time taken for intubation, number of attempts, fiberoptic grading, haemodynamic changes and complications if any will be assessed. Data will be compiled and appropriate statistical test will be done to analyse the result.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

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

入选标准

  • Adult patient 18 to 60 years of age of either sex , ASA physical status I or II , scheduled for elective surgery under general anaesthesia requiring intubation .

排除标准

  • Patients at risk of gastric content aspiration , anticipated difficult airway, interincisor gap <2.5cm , BMI >30, poor lung compliance and abnormal oropharyngeal anatomy .

结局指标

主要结局

1. Success rate of intubation.

时间窗: The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway . Data will be compiled and appropriate statistical test will be used to analyse the results

3. Time taken for insertion of device and intubation.

时间窗: The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway . Data will be compiled and appropriate statistical test will be used to analyse the results

2. Number of attempts.

时间窗: The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway . Data will be compiled and appropriate statistical test will be used to analyse the results

5. Fibre optic grading .

时间窗: The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway . Data will be compiled and appropriate statistical test will be used to analyse the results

7. Adverse effects .

时间窗: The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway . Data will be compiled and appropriate statistical test will be used to analyse the results

4. Ventilation through device.

时间窗: The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway . Data will be compiled and appropriate statistical test will be used to analyse the results

6. Haemodynamic parameters.

时间窗: The following will be assessed for both Air Q and Intubating Laryngeal Mask Airway . Data will be compiled and appropriate statistical test will be used to analyse the results

次要结局

  • 1. Success rate of intubation.(2. Number of attempts.)

研究者

发起方
Department of Anaesthesiology and Critical Care
申办方类型
Government medical college

研究点 (1)

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