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临床试验/NCT03610126
NCT03610126已完成不适用

Comparison of Efficacy of BASKA Laryngeal Mask Airway in Either Volume or Pressure Controlled Ventilation in Laparoscopic Cholecystectomy Comparative Clinical Trial

Assiut University1 个研究点 分布在 1 个国家目标入组 56 人开始时间: 2018年8月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
56
试验地点
1
主要终点
oropharyngeal leak pressure

研究概览

简要总结

this study will be undertaken to compare the efficacy of BASKA mask in volume controlled and pressure controlled ventilation in laparoscopic cholecystectomy.

详细描述

Laparoscopic cholecystectomy is one of the most commonly performed surgical procedures and the laryngeal mask airway (LMA) is the most common supraglottic airway device used by the anesthesiologists to manage airway during general anesthesia. Use of LMA has some advantages when compared to endotracheal intubation, such as quick and ease of placement, a lesser requirement for neuromuscular blockade and a lower incidence of postoperative morbidity. However, the use of the LMA in laparoscopy is controversial, based on a concern about increased risk of regurgitation and pulmonary aspiration. The ability of these devices to provide optimal ventilation during laparoscopic procedures has been also questioned. The most important parameter to secure an adequate ventilation and oxygenation for the LMA under pneumoperitoneum condition is its seal pressure of airway The BASKA mask is a novel supraglottic airway device. It has many of the features of other supraglottic airways, These include; A non-inflatable cuff, that it is continuous with the central channel of the device. As the pressure increases with positive pressure ventilation, the cuff itself is 'inflated', this may improve the seal, reduce leak, and make ventilation more efficient

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for elective cholecystectomy laparoscopic surgery.
  • Age: 18-60 years.
  • ASA physical status: I-II.

排除标准

  • Patient refusal.
  • History of cardiac disease, psychological disorders, respiratory diseases including asthma, renal or hepatic failure.
  • Patients who have high risk of regurgitation or aspiration based on history of gastro esophageal reflux, hiatus hernia, diabetes and gross obesity.
  • Neck pathology.
  • Patients who predicted difficult airway (based on a history of difficult airway, mouth opening was less than 2.5 cm, inter-incisor distance < 20 mm, cervical spine pathology, modified Mallampati class III/IV, or thyromental distance < 65 mm).
  • Preoperative sore throat.

结局指标

主要结局

oropharyngeal leak pressure

时间窗: Intra-operative

the oropharyngeal leak airway pressure will be used as a primary outcome to compare the efficacy of BASKA mask in volume controlled and pressure controlled ventilation in laparoscopic cholecystectomy and measuring leak pressure.

次要结局

  • End tidal carbon dioxide(Intraoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hala Saad Abdel-Ghaffar

Principal Investigator

Assiut University

研究点 (1)

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