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临床试验/CTRI/2013/08/003898
CTRI/2013/08/003898进行中(未招募)4 期

Comparison of i-gel with ProSeal laryngeal mask airway for airway management in paediatric patients

GOVERNMENT MEDICAL COLLEGE AND HOSPITAL1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年1月4日最近更新:

试验速览

阶段
4 期
状态
进行中(未招募)
发起方
入组人数
100
试验地点
1
主要终点
Oropharyngeal seal pressure

研究概览

简要总结

The study is a prospective  randomised  and controlled study comparing the efficacy of I -gel and ProSeal laryngeal mask airway for airway management in 100 children  between 2 to 6 years of age that will be conducted in Government medical college and Hospital, Chandigarh The primary outcome is oropharyngeal seal pressure in these two devices. The secondary outcomes are correct positioning insertion time quality of the initial airway fibroptic view  respiratory parameters including Peak airway pressure mean airway pressure minute ventilation resistance compliance  mean airway pressure at two five minutes post insertion of the device and hemodynamic parameters  at the start  after induction 2 mins and 5 mins after insertion of the device lastly after removal of the device The data will be analysed by SPSS software kolmogorov smirnov test will be used for normality of distribution Parametric data will be assessed by unpaired t test and non parametric data by mann whitney test  Data will be presented as mean SD

results demographic data similar in both groups The OLP  in i gel group  was significantly higher than in PLMA  group Time taken for successful insertion in PLMA was longer than in i gel group The quality of initial airway was found to be higher in i gel group

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant, Investigator and Outcome Assessor Blinded

入排标准

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

入选标准

  • 1.American Society of Anesthesiologist (ASA) physical status I/II of either sex 2.Age group of 2-6 years 3.Weight between 10-30 kg 4.Scheduled for short duration elective surgeries requiring general anaesthesia with controlled ventilation.

排除标准

  • 1.Upper respiratory tract infection 2.Anticipated difficult airway 3.Children at increased risk of aspiration.
  • Gastro esophageal reflux disease, non fasting status 4.Cardiorespiratory or cerebrovascular disease.

结局指标

主要结局

Oropharyngeal seal pressure

时间窗: just after insertion of the airway

次要结局

  • Number of Attempts(Insertion time (seconds))

研究者

发起方
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL
申办方类型
Government medical college

研究点 (1)

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