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临床试验/CTRI/2024/06/068284
CTRI/2024/06/068284尚未招募1/2 期

Comparison of efficacy of two anatomically preformed supraglottic devices for ventilation in paediatric patients undergoing elective surgery under general anaesthesia

Vardaman Mahavir Medical1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年6月12日最近更新:

试验速览

阶段
1/2 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
To compare oropharyngeal seal pressure of BlockBuster Laryngeal Mask airway with that of AmbuAuraGain in paediatric patients undergoing elective surgery under general anaesthesia

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. We hypothesis that BlockBuster Laryngeal Mask Airway has better efficacy for ventilation in terms of higher oropharyngeal seal pressure as compared to AmbuAuraGain in paediatric patients undergoing elective surgery under general anaesthesia.

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
1.00 Year(s) 至 10.00 Year(s)(—)
性别
All

入选标准

  • American Society of Anaesthesiologist Physical Status I and II and undergoing elective surgical procedures under general anaesthesia with controlled ventilation.

排除标准

  • Patients with anticipated difficult airway
  • Anticipated surgery time greater than 4 years
  • High risk of aspiration.

结局指标

主要结局

To compare oropharyngeal seal pressure of BlockBuster Laryngeal Mask airway with that of AmbuAuraGain in paediatric patients undergoing elective surgery under general anaesthesia

时间窗: Oropharyngeal seal pressure will be noted within 5 minutes after device insertion and the next reading will be taken after 30 minutes of device insertion.

次要结局

  • To compare following insertion characteristics of BlockBuster Laryngeal mask airway with that of Ambu AuraGain(Number of attempts taken for successful insertion of the device.)

研究者

发起方
Vardaman Mahavir Medical
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Vignesh Arumugasamy

Vardhaman Mahavir Medical College And Safdarjung Hospital, New Delhi

研究点 (1)

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