跳至主要内容
临床试验/NCT01267513
NCT01267513Unknown不适用

Noninvasive Ambulatory Measurements of Physiological Parameters Using a DLS-based Sensor

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2011年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
1
主要终点
Comparison of oxygen saturation and pulse rate between our sensor and conventional sensors

研究概览

简要总结

Ambulatory monitoring of physiological variables is important in following the health status of individuals in non-hospital controlled situations. The investigators are developing a non-invasive sensor based on dynamic light scattering that is able to measure pulse, blood flow and coagulability. Oxygen saturation can also be detected with minor modification of the apparatus. The investigators plan to validate the investigators sensor by applying it to patients in the intensive care unit, or to patients undergoing cardiac stress tests. The results of the investigators sensor will not be utilized for any therapeutic decisions, but will be collected for later comparison with conventional monitoring of pulse and oxygenation with standard monitors. The monitor is worn like a wrist watch, and will collect data into a small data storage disc for later analysis.

详细描述

Subjects to be studied will be either individuals undergoing routine cardiac stress tests, or patients admitted to the pulmonary ward of Meir Hospital who are being monitored in conventional manner. Normal volunteers will also be tested, under the following conditions: at rest, while running, while performing calisthenics, and while crawling on the ground. If non-inferiority of the new sensor is established compared to the standard clinically used sensors, then additional studies will be performed on acutely ill patients, such as patients admitted with multi-trauma.

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who are able to sign informed consent.
  • Patients undergoing standard cardiac stress tests who are able to sign informed consent.
  • Patients with pulmonary disease who are being monitored in a routine manner who are will ing to sign informed consent.

排除标准

  • Patients unable or unwilling to give consent

结局指标

主要结局

Comparison of oxygen saturation and pulse rate between our sensor and conventional sensors

时间窗: 0ne year

We wish to determine non-inferiority of our new sensor compared to current non-ambulatory sensors.

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 (1)

Loading locations...

相似试验

Ambulatory Measurements of Physiological Parameters | 临床试验