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

Oncology Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04914702
• Other study ID #: Bern/Basel 2021 WD Pilot
• Status: Completed
• Start date: September 16, 2021
• Est. completion date: March 1, 2022

Study information

• Verified date: July 2022
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 17 Years

Eligibility

Inclusion Criteria:

• Chemotherapy treatment because of any malignancy, expected to last =1 month at time of recruitment for myelosuppressive therapy; or at least one cycle of myeloablative therapy requiring autologous (Bern/Basel) or allogeneic (Basel) hematopoietic stem cell transplantation.

• Age from 1 month to 17.99 years at time of recruitment

• Written informed consent from parents and participants, where applicable

Exclusion Criteria:

• Local skin diseases prohibiting wearing of the WD.

• Denied written informed consent from participants

Related Conditions & MeSH terms

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

Intervention

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.
• 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.

Locations

Country	Name	City	State
Switzerland	University Children's Hospital Basel, University of Basel	Basel
Switzerland	Inselspital	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of continous recording of core temperature with the two wearable devices (WDs)	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.	14 days
Secondary	Feasibility of continous recording of heart rate with the Everion®	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.	14 days
Secondary	Feasibility of continous recording of heart rate variability with the Everion®	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.	14 days
Secondary	Feasibility of continous recording of respiration rate with the Everion®	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.	14 days
Secondary	Cumulative time of monitoring core temperature with the two wearable devices (WDs)	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.	14 days
Secondary	Cumulative time of monitoring heart rate with the Everion®	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.	14 days
Secondary	Cumulative time of monitoring heart rate variability with the Everion®	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.	14 days
Secondary	Cumulative time of monitoring respiration rate with the Everion®	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.	14 days
Secondary	Data arrival on the dashboard for core temperature (Everion®)	Cumulative length of time with data arrival on the dashboard =30 minutes after recording (continuous outcome, measured daily) for core temperature for the Everion®	14 days
Secondary	Data arrival on the dashboard for core temperature (CORE®)	Cumulative length of time with data arrival on the dashboard =30 minutes after recording (continuous outcome, measured daily) for core temperature for the CORE®	14 days
Secondary	Effort for investigators assessed by number of contacts	Cumulative number of contacts with the participants for the Investigators.	14 days
Secondary	Effort for investigators assessed by duration of contacts	Cumulative duration of contacts with the participants for the Investigators.	14 days
Secondary	Acceptability of Everion®	Proportion of participants indicating that continuous monitoring with the Everion® is acceptable (binary outcome, measured once).	14 days
Secondary	Acceptability of CORE®	Proportion of participants indicating that continuous monitoring with the CORE® is acceptable (binary outcome, measured once).	14 days
Secondary	Side Effects	Number and description of side effects reported by participants, if applicable (categorical outcome) and comparison of the side-effects of the two different WDs.	14 days
Secondary	User-friendliness	Comparison of the user-friendliness and preference of the different WDs as judged by the participants (categorical outcome, assessed with questionnaires)	14 days
Secondary	Comparison of core temperature with discrete measurements	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.	14 days
Secondary	Exploration	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.	14 days