跳至主要内容
临床试验/NCT03361553
NCT03361553已完成不适用

Developing a Novel Clinical Tool to Evaluate Obstructive Sleep Apnea (OSA) with Airway Ultrasound

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年7月20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
200
试验地点
1
主要终点
Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG)

研究概览

简要总结

Current practice guidelines recommend obstructive sleep apnea (OSA) patients to stay in the post anesthetic care unit (PACU) until the risk of respiratory depression has subsided. Inevitably, a greater demand on hospital resource utilization in these patients will increase health care cost. Polysomnography (PSG) and screening questionnaires can identify OSA but they are limited by accessibility and false positive results, respectively. Inaccurate OSA identification misguides postoperative surveillance plan. In contrast with MRI and CT scans, ultrasound is more accessible and more likely a practical tool for OSA screening. However, before clinical application, airway ultrasound (US) exam must undergo vigorous testing to check its utility, accuracy, inter-observer reliability and its ability to identify OSA and its severity.

详细描述

The investigators plan to recruit surgical patients at risk of OSA, exposed to sedatives,and/or general anesthesia. Surface ultrasound measurements will be conducted in a separate setting, and be correlated with the sleep study results, and a set of ultrasound parameters will be validated in this setting. Relevant clinical outcomes will be captured as well.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlation of airway parameter measurements with Apnea-Hypopnea Index (AHI) values on Polysomnography (PSG)

时间窗: 2 years

The primary study outcome will be the discriminatory performance of each one of the airway parameters, against the OSA status (moderate/severe) as diagnosed by PSG.

次要结局

  • Feasibility of airway Ultrasound (US) examination;(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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