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临床试验/NCT02698007
NCT02698007已完成不适用

Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy

Rabin Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
pulse oximetry <90%,

研究概览

简要总结

Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years.

Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough.

Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide.

Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation.

Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients.

Or benefits and safety LMA in front of intubation during bronchoscopy.

Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy .

Another objective, to examine whether there is a special group of patients enjoy the LMA more than others.

Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control.

Study group : LMA is inserted under sedation and used during the procedure.

Control group - performing bronchoscopy under sedation without LMA.

About 50 people are needed each group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • Above 18 y.o
  • Competency to sign informed consent.
  • Room air oxygen saturation above 95%
  • Stable hemodynamically and respiratory during the start procedure.
  • Undergoing elective bronchoscopy.

排除标准

  • Pregnant women and special groups will not be included in the study.

结局指标

主要结局

pulse oximetry <90%,

时间窗: during bronchoscopy procedure

Percutaneous Carbon Dioxide >55%,

时间窗: during bronchoscopy procedure

arrhythmia by ecg monitoring.

时间窗: during bronchoscopy procedure

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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