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临床试验/CTRI/2022/10/046760
CTRI/2022/10/046760尚未招募不适用

A Comparative Study of Respiratory mechanics in Patients undergoing day care laparoscopic cholecystectomy using LMA ProSeal vs LMA Protector.

Sir Ganga Ram Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年1月11日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
Comparison of dynamic compliance using LMA® ProSeal™ vs. LMA® Protector™ in patients undergoing lap cholecystectomy.

研究概览

简要总结

Minimally invasive laparoscopic surgery has revolutionized surgical practice and influenced the practice of anaesthesiology. Improvement in surgical and anaesthetic techniques has led to surgeries being performed on an outpatient basis with better pain management,early recovery and short duration of admission.General anaesthesia with controlled ventilation is the technique of choice in laparoscopic surgeries.

The record success of laryngeal mask airway in resuscitation, difficult airway management and anaesthesia lead to the introduction of several supraglottic airway devices (SADs) into clinicalpractice.SADsoffer several advantages over endotracheal tubes including ease of insertion, reduced haemodynamic response,decreased airway tolerance and lesser pharyngolaryngealmorbidity.1-5 The introduction of second-generation SADs having gastric drainage tube provide a better oropharyngeal seal and improved protection against regurgitation and pulmonary aspiration.

LMA®  Protectorâ„¢ is a recently developed SAD  with few published studies on its utility to date. It is made of medical-grade silicone which makes it more flexible and less traumatic than previous LMA devices made up of PVC. It is a single-use second generation SAD designed with a large volume conduit with gastric assess and a fixed curved structure to facilitate insertionand an inflatable airway cuff.6 Additionally, the LMA  Protector is available with a pilot balloon or the integrated cuff pilot that provides easier adjustment of the intracuff pressure.7

Since LMA®  Protectorâ„¢ was introduced in 2015 as the most advanced second-generation device, we want to compare this device with LMA® ProSealâ„¢, one of the most frequently used devices in any institution. Until now, only a few studies have compared the clinical efficacy of the LMA®  Protectorâ„¢ with other SADs.

In this study, we aim to compare the respiratory mechanics with LMA® ProSealâ„¢ *vs.*LMA®  Protectorâ„¢ in patients undergoing day care laparoscopic cholecystectomy.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • ASA physical status 1 and 2 2.

排除标准

  • Patient with upper respiratory tract infection
  • Patient at risk of aspiration
  • Anticipated difficult airway
  • Patient with lung disease patient refusal.

结局指标

主要结局

Comparison of dynamic compliance using LMA® ProSeal™ vs. LMA® Protector™ in patients undergoing lap cholecystectomy.

时间窗: 1.At insertion of the device | 2.At 5 minutes after insertion of the device. | 3.At 10 minutes after insertion of the device | 4.At the initiation of carboperitoneum | 5.At 5 minutes of carboperitoneum | 6.At 10 minutes of carboperitoneum | 7.At 20 minutes of carboperitoneum | 8.At the release of carboperitoneum | 9.5 minutes afterthe release of carboperitoneum | 10.10 minutes after the release of carboperitoneum

次要结局

  • Comparison of(Airway resistance)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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