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临床试验/CTRI/2019/03/017981
CTRI/2019/03/017981已完成2/3 期

A RCT COMPARING EFFICACY& COMPLICATIONS BETWEENBASKA MASK AND CLASSICLARYNGEAL MASK AIRWAY INANAESTHETIZEDSPONTANEOUSLYBREATHING PATIENTS

SRM MCH RC1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年6月4日最近更新:
适应症

试验速览

阶段
2/3 期
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
1 Number of attempt taken for insertion of device

研究概览

简要总结

Maintenance of airway is of extreme importance in patients undergoing anesthesia for surgical procedures. From time to time there has been multiple gadgets used to maintain oxygenation. Laryngeal mask airways have come a long way as easy to use, handy instrument for airway maintenance.

The problem with LMA is aspiration. BASKA mask is 3rd generation LMA which claims that the seal produced in pharynx is better and there is no chance of aspiration. In addition there is a sump in the gadget which drains the fluid collected in the oesophagus by active suction

There are hardly any studies where BASKA msk has been compared

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 60.00 Year(s)(—)
性别
Female

入选标准

  • •ASA 1 and ASA 2 MPC 1 and 2 Elective minor procedures.

排除标准

  • •ASA 3 and ASA 4 Patients with difficult intubation Emergency surgeries.

结局指标

主要结局

1 Number of attempt taken for insertion of device

时间窗: 1 Number of attempt taken for insertion of device | 2 Time taken to insert the device | 3 Measurement of pressure required to elicit leak after inserting the device | 4 Ease of intubating with device

2 Time taken to insert the device

时间窗: 1 Number of attempt taken for insertion of device | 2 Time taken to insert the device | 3 Measurement of pressure required to elicit leak after inserting the device | 4 Ease of intubating with device

3 Measurement of pressure required to elicit leak after inserting the device

时间窗: 1 Number of attempt taken for insertion of device | 2 Time taken to insert the device | 3 Measurement of pressure required to elicit leak after inserting the device | 4 Ease of intubating with device

4 Ease of intubating with device

时间窗: 1 Number of attempt taken for insertion of device | 2 Time taken to insert the device | 3 Measurement of pressure required to elicit leak after inserting the device | 4 Ease of intubating with device

次要结局

  • 1 Changes in pulse rate(2 Changes in blood pressure)

研究者

发起方
SRM MCH RC
申办方类型
Private medical college

研究点 (1)

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