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临床试验/CTRI/2024/05/066827
CTRI/2024/05/066827尚未招募不适用

Efficacy of LMA Protector in laparoscopic cholecystectomy

MS Ramaiah medical college1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2024年5月31日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
87
试验地点
1
主要终点
To assess the efficacy of LMA® Protector™ in laparoscopic cholecystectomy

研究概览

简要总结

Supraglottic airway devices (SADs) have grown in popularity for airway management since their introduction into the practice of clinical anaesthesia. Laparoscopic cholecystectomy is a commonly performed surgical procedure and is usually carried out under general anaesthesia with endotracheal intubation. Supraglottic airway devices have been used as an alternative to endotracheal intubation in laparoscopic surgeries. However, the concerns with the use of SADs in laparoscopic surgery include potential risk of regurgitation, aspiration, and inadequate ventilation from pneumoperitoneum induced changes in airway pressure and pulmonary compliance.

The oropharyngeal leak pressure (OLP) or sealing pressure is a measure of the capability of a SAD to protect against the risk of aspiration as well as to achieve adequate positive pressure ventilation.  There were functional improvements implemented to newer SAD.The LMA® Protectorâ„¢ Cuff Pilotâ„¢ (Teleflex Medical Europe Ltd, Athlone, Ireland) is a recently introduced second generation SAD made of medical grade silicone that provides access as well as functional separation of respiratory and digestive tracts. The medical grade silicone inflatable cuff is thought to improve the ability of LMA® Protectorâ„¢ to provide high OLP and effective ventilation.

Currently there is paucity of literature detailing the efficacy of LMA® Protector™ in laparoscopic surgeries and hence this study is designed to evaluate its role in laparoscopic cholecystectomy with the hypothesis that LMA® Protector™ may be efficacious in laparoscopic cholecystectomy.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • American society of Anaesthesiologists ASA physical status 1 and 2 patients undergoing laparoscopic cholecystectomy.

排除标准

  • BMI more than 30 kg/m2 Weight more than 100 kg Gastro-oesophageal reflux disease Known or anticipated difficult airway Upper airway pathology Recent upper respiratory tract infection Mouth opening less than 2 cm.

结局指标

主要结局

To assess the efficacy of LMA® Protector™ in laparoscopic cholecystectomy

时间窗: 5minutes after the end of laparoscopic cholecystectomy

次要结局

  • Ease of insertion(2 minutes after insertion of LMA)
  • Number of attempts of insertion with LMA(5minutes after insertion of LMA)
  • Oropharyngeal leak pressure with LMA(1minute after insertion of LMA)
  • Ease of gastric tube insertion(3minutes after insertion of LMA)
  • Position of LMA® Protectorâ„¢ in relation to laryngeal inlet(2 minutes after insertion of LMA)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Yammini R

MS Ramaiah Medical College

研究点 (1)

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