Cancer
Conditions
Brief summary
Clinical data validation of the C3 device as a Vital Sign Monitoring System for patients under cancer treatment.
Detailed description
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.
Interventions
DEVICECortrium C3 device
Paired measurements of data from C3 device with golden standard methods or equipment
Sponsors
University College Absalon
Cortrium
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulse rate | May 2017-March 2018 | Continuous measurements from C3 device. Punctual measurement observed by the healthcare personnel |
| Respiratory rate | May 2017-March 2018 | Continuous measurements from C3 device. Punctual measurement observed by the |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Infection | May 2017-March 2018 | Exploratory study - Comparison of all sensors embedded within the C3 device to the patient infection level (measured as fever) |
| Design & Workflow studies | May 2017-March 2018 | Observational studies and interviews with healthcare personnel and patients regarding the C3 device. |
Countries
Germany
Outcome results
None listed