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临床试验/NCT03603860
NCT03603860已完成不适用

Comparison of Continuous Blood Pressure Measurement Using the Non-invasive, Wireless Biobeat Monitor With an Invasive Arterial Line

Biobeat Technologies Ltd.1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年11月5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
18
试验地点
1
主要终点
Level of accordance between the Biobeat monitor and the arterial line

研究概览

简要总结

In this clinical study the investigators will compare blood pressure measurements obtained using the non-invasive, continuous and wireless Biobeat monitoring device (a wrist watch or a patch configuration) to an invasive arterial line (radial or femoral) in 30 patients immediately after cardiac surgery, at the intensive care unit.

详细描述

The Biobeat non-invasive, continuous and wireless monitoring device is based on photoplethysmograph technology. It measures several vital signs, including blood pressure, stroke volume, pulse rate, pulse pressure, heart rate variability, respiratory rate, saturation, cardiac output, cardiac index, and more. The data is transmitted to Biobeat's application (in both Apple and Google Play), and is available on the individual's cellular phone, tablet, or as a full monitoring system in a hospital department. The aim of this study is to compare the Biobeat monitor with the invasive method of blood pressure measurement, an arterial line. The study population includes 30 patients undergoing cardiac surgery. As per local protocol, each one of the participants will come out from the operating room with an arterial line. Once in the intensive care unit, the investigators will attach the Biobeat non-invasive monitor (either wrist watch or a patch, these two configurations are identical in terms of the monitoring system), and monitor the participants for 4 hours. Though both methods are continuous, the investigators will record the vital signs every 15 minutes during the 4 hours of the study.

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

  • Patients arriving immediately after cardiac surgery to the intensive care unit with an arterial line.

排除标准

  • Refusal to participate
  • Patients with no arterial line
  • Pregnant women
  • Individuals under the age of 18 years
  • Patients with lack of judgment/mental illness
  • Patients working in the Baruch Padeh Medical Center

结局指标

主要结局

Level of accordance between the Biobeat monitor and the arterial line

时间窗: 4 hours per individual

Comparing blood pressure measurements of the Biobeat device with those of the arterial line. Both systolic blood pressure and diastolic blood pressure will be assessed during the study period.

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 (1)

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