NCT Number: NCT04914702
In this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied.
Vital signs and are recorded with two different wearable devices (WDs): Everion®, by Biovotion (now Biofourmis), Zurich, Switzerland and CORE® by GreenTEG, Zurich, Switzerland. Patients can choose if they want to wear one or both WDs during this study. Those opting to wear two WDs can choose if they want to wear them in parallel, or sequentially.
Results from the two different WDs will be compared. Study duration for each participant is 14 days per device.
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Notify Me1 month–17 year
All sexes
Observational
University Children's Hospital Basel, University of Basel, Basel, Switzerland
In a previous study (Bern 2019 WD Pilot, NcT04134429) the investigators found that continuous recording of vital signs with the Everion® is feasible in good quality across a wide age range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. However, the pre-defined criterion to claim feasibility was not formally reached and low compliance was the main reason identified.
In this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the Everion®.
Second, the investigators want to assess the feasibility of a second device, made commercially available only in October 2020, the CORE® WD by GreenTEG. Results from the two different wearable devices will be compared. Study duration for each participant is 14 days per device.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The Everion® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
The CORE® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
Time frame: 14 days
The primary outcome is defined as at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best); CORE® ≥2, quality score 1 (lowest) to 4 (best)) of core temperature measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
Time frame: 14 days
At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of heart rate measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
Time frame: 14 days
At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of heart rate variability measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
Time frame: 14 days
At least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best) of respiration rate measurement, with arrival on dashboard ≤30 minutes after recording, during a cumulative duration of ≥18/24h per day (midnight to midnight), on ≥7 days within the 14 days of the study period.
Time frame: 14 days
Cumulative length of time with recorded core temperature with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best); CORE® ≥2, quality score 1 (lowest) to 4 (best)) per study day.
Time frame: 14 days
Cumulative length of time with recorded heart rate with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.
Time frame: 14 days
Cumulative length of time with recorded heart rate variability with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.
Time frame: 14 days
Cumulative length of time with recorded respiration rate with at least sufficient data quality (Everion® ≥50, quality score 0 (lowest) to 100 (best)) per study day.
Time frame: 14 days
Cumulative length of time with data arrival on the dashboard ≤30 minutes after recording (continuous outcome, measured daily) for core temperature for the Everion®
Time frame: 14 days
Cumulative length of time with data arrival on the dashboard ≤30 minutes after recording (continuous outcome, measured daily) for core temperature for the CORE®
Time frame: 14 days
Cumulative number of contacts with the participants for the Investigators.
Time frame: 14 days
Cumulative duration of contacts with the participants for the Investigators.
Time frame: 14 days
Proportion of participants indicating that continuous monitoring with the Everion® is acceptable (binary outcome, measured once).
Time frame: 14 days
Proportion of participants indicating that continuous monitoring with the CORE® is acceptable (binary outcome, measured once).
Time frame: 14 days
Number and description of side effects reported by participants, if applicable (categorical outcome) and comparison of the side-effects of the two different WDs.
Time frame: 14 days
Comparison of the user-friendliness and preference of the different WDs as judged by the participants (categorical outcome, assessed with questionnaires)
Time frame: 14 days
Difference between discrete measurements of core temperature, performed by the participants, if applicable, twice daily or more if clinically indicated and the measured signal from both WDs at the corresponding time.
Time frame: 14 days
Exploration of potential changes in or specific patterns of all measured signals within 48 hours before clinical diagnosis of fever, with or without neutropenia, if applicable.
Insel Gruppe AG, University Hospital Bern
Other
Continuous Monitoring of Vital Signs With Different Wearable Devices in Pediatric Patients Undergoing Chemotherapy for Cancer - a Comparison and Feasibility Pilot Study
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