Clinical data validation of the C3 device as a Vital Sign Monitoring System for patients under cancer treatment.
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.
Study Type
OBSERVATIONAL
Enrollment
21
Paired measurements of data from C3 device with golden standard methods or equipment
University Medical Center Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, Germany
Pulse rate
Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel
Time frame: May 2017-March 2018
Respiratory rate
Continuous measurements from C3 device. Punctual measurement observed by the
Time frame: May 2017-March 2018
Infection
Exploratory study - Comparison of all sensors embedded within the C3 device to the patient infection level (measured as fever)
Time frame: May 2017-March 2018
Design & Workflow studies
Observational studies and interviews with healthcare personnel and patients regarding the C3 device.
Time frame: May 2017-March 2018
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