跳至主要内容
临床试验/CTRI/2021/12/038687
CTRI/2021/12/038687尚未招募不适用

Comparative Evaluation Of Laryngeal Mask Airway Protector Versus Laryngeal Mask Airway Proseal In Anaesthetised, Paralysed Patients

Maulana Azad Medical College1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2021年12月25日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
250
试验地点
1
主要终点
Insertion Time

研究概览

简要总结

Laryngeal Mask Airway Protector is latest second generation airway device introduced in 2015 combining pharyngeal chamber and dual gastric drainage channels. There is paucity of studies which compared LMA Protector to other supraglottic airway device. The present study is proposed to compare the performance of LMA Protector to LMA Proseal in 250 patients undergoing elective surgeries under anaesthesia. Adult patients aging 18- 65 years of either sex and those belonging to ASA PS I and II who was scheduled to undergo elective surgeries under general anaesthesia with supraglottic device will be recruited for participation in study. Pregnant patients those having BMI >35  kg/m2 and patients at increased risk of aspiration will be excluded. Patients will be randomly allocated into 2 groups ; in group 1 ( LMA Protector group) in group 2 ( LMA Proseal).Standard technique of anaesthesia will be used in both groups. As per group allocation either LMA Protector or LMA Proseal will be used for securing airway of patients. 3 attempts will be allowed for successful placement in either groups. Primary objective will be time taken for successful insertion of LMA Protector and LMA Proseal. Secondary objectives will be ; to compare number of attempts for successful insertion; to compare the ease of insertion of nasogastric tubes through LMA Protector and LMA Proseal; to see correct placement by fibreoptic evaluation. Collected data will be entered in Microsoft excel and then will be analysed and statistically evaluated using SPSS-25.0 version. Appropriate statistical tests will be applied.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization

入排标准

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

入选标准

  • Age 18 to 65 years of either sex.
  • American Society Of Anaesthesiologists(ASA) Class 1 and 2.

排除标准

  • Patients at increased Risk of Aspiration or GERD.
  • BMI >35kg/m2 3) Pregnancy.

结局指标

主要结局

Insertion Time

时间窗: At Baseline

次要结局

  • 1.Number of attempts(2.Ease of gastric tube placement)

研究者

申办方类型
Government medical college

研究点 (1)

Loading locations...

相似试验