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临床试验/NCT03387891
NCT03387891已完成不适用

Clinical Testing on Newly Developed Monitoring Technology (The Cortrium C3 Device) for Continuous Measurements of ECG, Respiratory Rate, Body Surface Temperature and Accelerometer Data for Patients With Cancer

Cortrium1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2017年5月3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
Cortrium
入组人数
21
试验地点
1
主要终点
Respiratory rate

研究概览

简要总结

Clinical data validation of the C3 device as a Vital Sign Monitoring System for patients under cancer treatment.

详细描述

Cortrium has developed the C3 device. The C3 device contains sensors that monitors Electrocardiogram (ECG), Respiratory rate (breathes per minute), and Body surface temperature. Also, the C3 device contains an accelerometer for registration of the body posture.

The following thesis will be tested:

Thesis 1) Pulse: The C3 device produces clinically validated pulse data. Thesis 2) Respiratory rate: The C3 device produces clinically validated respiratory rate data (breaths per minute). Thesis 3) Infection: With no justified statistical significant correlation between skin and body temperature, the study is exploring how to prevent aggravated or lethal outcomes of cancer treatment, e.g. chemotherapy, by using vital signs measurements combined with accelerometer data to detect infection levels. Thesis 4) The qualitative study: The study will report the advantages and disadvantages regarding new technological solutions, and the change in workflow and healthcare provision as it is experienced by the healthcare personnel and the patients. The data validation studies (thesis 1-3) will be tested in comparison with golden standard measurements methods and/or data validated medical equipment.

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

  • Legally competent persons - i.e., patients considered able to understand the information given about the clinical trial
  • Person is 18 years or older
  • Person has given a written informed consent

排除标准

  • Not legally competent patients
  • Pregnant and lactating women
  • Fertile women, who do not use contraceptives
  • Patients under 18 years
  • Patients with known heart-related disease

结局指标

主要结局

Respiratory rate

时间窗: May 2017-March 2018

Continuous measurements from C3 device. Punctual measurement observed by the

Pulse rate

时间窗: May 2017-March 2018

Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel

次要结局

  • Infection(May 2017-March 2018)
  • Design & Workflow studies(May 2017-March 2018)

研究者

发起方
Cortrium
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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