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临床试验/CTRI/2024/08/072295
CTRI/2024/08/072295尚未招募2/3 期

Comparison of efficacy of two single use supraglottic airway devices for ventilation in adult patients undergoing elective surgery under general anaesthesia

VMMC and Safdarjung hospital New Delhi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年8月21日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
To compare efficacy of BlockBuster Laryngeal Mask Airway for ventilation with that of Ambu AuraGain in adult patients.

研究概览

简要总结

The supraglottic airway devices(SADs) are commonly used for airway management during anaesthesia or as an immediate life-saving measure in patients with difficult or failed airway. The second generation SADs make two separate seals with respiratory and gastrointestinal tracts to reduce risk of pulmonary aspiration. Ambu AuraGain is a newer single use anatomically curved supraglottic airway device with a gastric conduit and intubation capability. The integrated gastric access channel is designed with a low friction inner surface to facilitate easy placement of a gastric tube.

BlockBuster Laryngeal Mask Airway has a short airway tube which has angulation to match the oropharyngeal curve and thus makes the insertion easy and less traumatic. It also has a gastric conduit and intubation capability. It has a guidance device which directs the tracheal tube towards the laryngeal opening at an angle of 30 degrees which enhances rate of successful blind intubation. The subjects are divided into 2 groups ( group A- Ambu AuraGain inserted and group B- BlockBuster LMA inserted) using block randomisation and allotted into 1 of the 2 groups. We hypothesize that Ambu AuraGain has better efficacy for ventilation as compared to BlockBuster LMA in terms of oropharyngeal leak pressure in adult patients undergoing elective surgery under general anaesthesia with controlled ventilation.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Age group 18-60 years.
  • weight 30-70 kgs.
  • ASA grade 1 and 2.

排除标准

  • Patients with anticipated difficult airway.
  • Body Mass Index more than 30kg/m
  • High risk of aspiration.

结局指标

主要结局

To compare efficacy of BlockBuster Laryngeal Mask Airway for ventilation with that of Ambu AuraGain in adult patients.

时间窗: At base line

次要结局

  • To compare insertion characteristics of BlockBuster Laryngeal Mask Airway & Ambu AuraGain.(At base line)

研究者

发起方
VMMC and Safdarjung hospital New Delhi
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Manu Kumar Singh

Vardhman Mahavir Medical College and Safdarjung hospital

研究点 (1)

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