NCT04914702

Feasibility and Comparison of Continuously Monitored Vital Signs in Pediatric Patients With Cancer.

Continuous Monitoring of Vital Signs With Different Wearable Devices in Pediatric Patients Undergoing Chemotherapy for Cancer - a Comparison and Feasibility Pilot Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Insel Gruppe AG, University Hospital Bern · Academic / Other
• Sex: All
• Age: 1 Month – 17 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pediatric Cancer
• Febrile Neutropenia
• Oncology
• Chemotherapy-induced Neutropenia

Interventions

Type	Name	Description
DEVICE	Everion®	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.
DEVICE	CORE®	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.

Timeline

• Start date: 2021-09-16
• Primary completion: 2022-03-01
• Completion: 2022-03-01
• First posted: 2021-06-07
• Last updated: 2022-07-11

Locations

2 sites across 1 country: Switzerland