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临床试验/CTRI/2023/01/049046
CTRI/2023/01/049046尚未招募不适用

A Prospective randomised study comparing pressure controlled ventilation and volume controlled ventilation using I-gel during gynaecological laparoscopy

Calcutta National Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年1月16日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1
主要终点
Peak inspiratory pressure

研究概览

简要总结

80 female patients ( ASA 1 and 2), candidates for elective gynaecological surgeries of duration less than 90 minutes will be enrolled for this prospective randomised study after taking written consent from the patients.The participants will be randomly assigned  to receive pressure controlled ventilation (PCV) or volume controlled ventilation (VCV) after insertion of I-gel by standard technique. In VCV group,  ventilation will be done with tidal volume of 10ml/kg ideal body weight (IBW)and in PCV group, baseline ventilation will be done with a peak inspiratory pressure that provides a tidal volume of 10ml/kg IBW. Peak inspiratory pressure and other lung mechanics and hemodynamic response will be compared at 5 minutes after I-gel insertion, 5 and 15 minutes after pneumonia-peritoneum and thereafter 15 minutes till extubation.

研究设计

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

入排标准

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

入选标准

  • ASA grade 1 and 2 Patient undergoing elective short duration ( less than 90 minutes) gynaecological laparoscopic surgeries.

排除标准

  • Patient refusal 2)BMI> 30 kg/m2 3)ASA grades 3,4,5 and emergency 4) Patients with difficulty in mouth opening 5) Upper airway abnormalities 6)Macroglossia 7) Pregnancy and breast feeding mothers 8) Recent head and neck surgeries.

结局指标

主要结局

Peak inspiratory pressure

时间窗: Just after insertion of I-gel, 5 minutes and 15 minutes after pneumonia-peritoneum, thereafter 15 minutes till extubation

次要结局

  • Lung mechanics(Hemodynamic response)

研究者

发起方
Calcutta National Medical College and Hospital
申办方类型
Government medical college

研究点 (1)

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