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
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
- 否
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)
