Comparison of clinical performance of i-gel and Ambu AuraGain in paedidatric patients - A randomized controlled study

Sarayu V1 个研究点分布在 1 个国家目标入组 40 人开始时间: 2020年10月6日最近更新: 2020年9月5日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 40
试验地点: 1
主要终点: The difference in outcome between oropharyngeal sealing pressure at 1 in after successful insertion and 10 min after insertion of the device

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The trial is a randomized,single blinded, to determine the oropharyngeal sealing presssure and the changes in oropharyneal sealing pressure during 10 mins.The secondary outcome includes, the insertion time and success rate at first attempt,the degree of ease of gastric tube insertion and peri-operative adverse effects. All children ,scheduled at a tertiary care hospital for elective paediatric surgery under general anaesthesia not requiring tracheal intubation will be the potential study population.The duration of the study will be for 18 months.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Outcome Assessor Blinded

入排标准

年龄范围: 6.00 Month(s) 至 6.00 Year(s)（—）
性别: All

入选标准

•All children(both boys and girls)aged between 6 months and 6 years old with ASA 1-3 and weight between 5 and 20 kgs.

排除标准

•Known difficult airway,high risk of aspiration including those with gastro-intestinal stenosis or stricture, symptoms or signs of upper respiratory tract infection,patients who deny consent.

结局指标

主要结局

The difference in outcome between oropharyngeal sealing pressure at 1 in after successful insertion and 10 min after insertion of the device

时间窗: All patients for 18 months period

次要结局

The difference in outcome in terms of insertion time and success rate at first attempt,the degree of ease of gastric tube insertion,peri-operative adverse effects.(All patients for 18 months period)

研究者

发起方

Sarayu V

申办方类型

Other [self]

研究点 (1)

Loading locations...

相似试验

进行中（未招募）

4 期

Clinical trial comparing the advantage of use of i- gel over ProSeal airway device in children

CTRI/2013/08/003898GOVERNMENT MEDICAL COLLEGE AND HOSPITAL100

已完成

不适用

A randomised crossover trial comparing the laryngeal mask ProSeal and the i-gel supraglottic airwayDiseases requiring operation under general anesthesia

JPRN-UMIN000006030Osaka City General Hospital and Children's Hospital300

已完成

不适用

Comparison of I-gel to the Laryngeal Mask AirwayEndotracheal IntubationSupraglottic Airway

NCT00706823The University of Texas Health Science Center, Houston50

招募中

不适用

LMA I-Gel Versus LMA Protector During Minor Urological Procedures Under General Anesthesia in Adult Patients

NCT06825910Nikolopoulou Maria Zozefin100

尚未招募

不适用

Comparison of the clinical performance of airway devices in geriatric patients-Urologic conditions-General surgery conditions

ACTRN12618001473257Reyhan Polat105