跳至主要内容
临床试验/NCT02639884
NCT02639884已完成不适用

Correlation of Endoscopic View of Airway Obstruction With RRa Signal in OSA Patients Under Dexmedetomidine Anesthesia Monitored With SedLine EEG

Masimo Corporation2 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2015年12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
51
试验地点
2
主要终点
Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected

研究概览

简要总结

Patients with obstructive sleep apnea (OSA) could have several anatomical causes of obstruction. A sleep endoscopy study is a technique to help determine the anatomical cause of OSA. This study will be using standard of care practice and infuse dexmedetomidine (DEX) to induce sleep. The goals of the study are to (1) confirm airway obstruction with endoscopic view and correlate that with Acoustic Respiratory Rate (RRa) signal at the moment of airway obstruction, and (2) characterize the EEG signals when subjects are under DEX sedation alone.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Adult patients more than 18 years old with American Society of Anesthesiologists (ASA) classification of I, II, or III.
  • Patients undergoing sedation for sleep endoscopy with DEX alone, and possible surgical follow-up.

排除标准

  • ASA classification higher than III.
  • Any deformities or diseases that may prevent application of SedLine (Masimo Sedation Monitoring) or RAM (Masimo Rainbow Acoustic Monitoring) sensors with a proper fit
  • Inability to obtain any physiological, vital, demographics and real time anaesthesia data
  • Subjects who have known intolerance to any of the drugs to be used according to the study protocol
  • Subjects deemed not suitable for study at the discretion of the Principal Investigator.

结局指标

主要结局

Number of Subjects in Which Electroencephalogram (EEG) Signals is Collected

时间窗: One visit

Subjects enrolled into the study will have the SedLine sensor placed on the subject to collect EEG signals.

Number of Subjects in Which Acoustic Respiratory Rate (RRa) Signals is Collected

时间窗: One visit

All subjects enrolled into the study will receive the RAM sensor in order to records RRa signals.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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