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临床试验/CTRI/2024/05/067856
CTRI/2024/05/067856尚未招募4 期

The influence of positive end expiratory pressure on leakage and oxygenation during ventilation with laryngeal mask airway:A randomized trial

Dr Nagma Qadir1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2024年6月15日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
400
试验地点
1
主要终点
To find difference between PEEP and ZEEP with respect to gas leakage in patients receiving positive pressure ventilation with ProSeal LMA mask.

研究概览

简要总结

To clarify the potential benefit or harm to PEEP application during positive pressure ventilation with a Proseal LMA mask,we plan to compare the effect of PEEP versus ZEEP on gas leakage and oxygenation.we hypothesized that a PEEP of 4cm.This study will be prospective,controlled,randomized,single blinded conducted at a single centre.Using a computer generated randomization system,p atients were randomized to positive pressure ventilation with zero end -expiratory pressure or a PEEP of 4mbar.Age will be in between 1 to 18 year.Gas leakage are determined by seeing the difference in tidal delivered using values provided by machine and the presence of audible gas leakage.Based on that ,the qualityof ProSeal LMAmask placement and adequacy of ventilation would also be evaluated by the anaesthesiologist.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

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

入选标准

  • Patient undergoing elective surgery with general anaesthesia and ventilation with laryngeal mask 2)ASA 1 or 2 3)Age less than 18 years.

排除标准

  • Patient at risk of aspiration Gastroesophageal reflux disease BMI percentile 95 or greater Surgical procedures in prone or lateral positions and laproscopic surgeries.

结局指标

主要结局

To find difference between PEEP and ZEEP with respect to gas leakage in patients receiving positive pressure ventilation with ProSeal LMA mask.

时间窗: Intraoperative period

次要结局

  • To clearify the potential benefit or harm to PEEP application during Positive pressure with ventilation with(Proseal LMA mask)

研究者

发起方
Dr Nagma Qadir
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Nagma Qadir

Indira Gandhi Institute of Medical Sciences

研究点 (1)

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