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临床试验/CTRI/2023/08/056721
CTRI/2023/08/056721尚未招募不适用

Orophayrngeal seal pressure and peak airway pressure between Baska mask and I gel in patients undergoing laparoscopic surgeries: A randomized controlled trial.

Department of Anesthesiology and critical care1 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9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
1.To determine oropharyngeal Seal Pressure in baska mask & I-gel after creating

研究概览

简要总结

Airway management is considered as an integral part of general anesthesia. Endotracheal

intubation has been considered as a conventional gold standard method for securing the airway

during GA.1 In the last few years , many supraglottic airway devices (SADs) have been

introduced in clinical practice. Supraglottic airway devices has changed the scenario from

’unable to intubate and ventilate’ to ’unable to intubate but able to ventilate’.1 These devices has

much importance for patients with difficult tracheal intubation or where intubation is

impossible. 1 Oropharygeal seal pressure and peak airway pressure is an important parameter

for safe use during laparoscopic surgeries.

In this study, we evaluated the performance of the baska mask , a new extraglottic airway

device (EAD) for use in anesthesia in adult patients undergoing a variety of surgical

interventions.

The purpose of this study is to compare the oropharyngeal seal pressure and peak airway

pressure between baska mask and I gel after creating pneumoperitoneum in laparoscopic

surgeries.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Double Blind Double Dummy

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 80 patients of either sex, aged 18–60 years, belonging to American Society of Anaesthesiologists (ASA) physical status class I and II presenting for laparoscopic surgery under general anaesthesia will be included in the study.

排除标准

  • Patient refusal to consent Obesity (body mass index ≥30 kg/m2) Pregnancy Known or predicted difficult airway (Mallampati grade 3/4, mouth opening < 3 cm, thyromental distance < 6cm , positive upper lip bite test) Reduced lung compliance High risk for pulmonary aspiration (non fasted, gastroesophageal reflux disease) Patients with known cardiorespiratory illness.

结局指标

主要结局

1.To determine oropharyngeal Seal Pressure in baska mask &amp; I-gel after creating

时间窗: Measured at 1 min after induction, at 5 mins before and after creating pneumoperitoneum, and at 5 mins before and after deflation of pneumoperitoneum.

pneumoperitoneum in patients undergoing laparoscopic surgeries.

时间窗: Measured at 1 min after induction, at 5 mins before and after creating pneumoperitoneum, and at 5 mins before and after deflation of pneumoperitoneum.

2.To determine peak airway pressure in baska mask &amp; I-gel after creating

时间窗: Measured at 1 min after induction, at 5 mins before and after creating pneumoperitoneum, and at 5 mins before and after deflation of pneumoperitoneum.

次要结局

  • To determine ease of insertion & time of insertion in baska mask and I gel.(It is taken as the time from picking up the device till)

研究者

发起方
Department of Anesthesiology and critical care
申办方类型
Government medical college

研究点 (1)

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