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临床试验/NCT04686656
NCT04686656已完成不适用

A Randomized Controlled Trial Comparing Nasal With Buccal Oxygen Administration for Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration

Antalya Training and Research Hospital2 个研究点 分布在 2 个国家目标入组 60 人开始时间: 2020年12月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
hypoxia-related interruptions

研究概览

简要总结

The purpose of this study is to compare to nasal and buccal oxygen administration in patients undergoing Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration .

详细描述

Anesthesia for Endobronchial Ultrasound (EBUS) may be range from routine bronchoscopy sedation to general anesthesia. During sedation to EBUS increased duration of anesthesia and sedative dosing put patients at increased risk for hypoxic events. To avoid this, oxygen supplementation is mandatory. There are different techniques for oxygen supplementation during the procedure. At this study we will compare to nasal and buccal oxygen supplementations during EBUS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients ≥18 years of age
  • body mass index (BMI) between 20 and 30
  • American Society of Anesthesiologists physical status I-III

排除标准

  • congestive heart failure
  • ischemic heart disease
  • increased intracranial pressure
  • known allergy or contraindication to study drugs (propofol, fentanyl, or midazolam)
  • an anatomical feature precluding adequate positioning of the buccal device.

结局指标

主要结局

hypoxia-related interruptions

时间窗: 30 minutes

the number of hypoxia-related interruptions

次要结局

  • duration of procedure(30 minutes)
  • satisfaction of pulmonary specialist(30 minutes)
  • use of propofol(30 minutes)
  • use of fentanyl(30 minutes)

研究者

发起方
Antalya Training and Research Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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