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

NCT04914702 | Completed

• 1 other identifier: Bern/Basel 2021 WD Pilot
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

Wearable device; Everion®; CORE®; Continuous recording; Vital signs; Pediatric oncology

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Feasibility of continous recording of heart rate with the Everion®

  14 days

• Feasibility of continous recording of heart rate variability with the Everion®

  14 days

• Feasibility of continous recording of respiration rate with the Everion®

  14 days

• Cumulative time of monitoring core temperature with the two wearable devices (WDs)

  14 days

• Cumulative time of monitoring heart rate with the Everion®

  14 days

Study Arms (5)

Everion® only

Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, 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: Everion®

CORE® only

A CORE® device will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.

Device: CORE®

Everion® first, CORE® second

Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, 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. Then a CORE® device will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene.

Device: Everion®; Device: CORE®

CORE® first, Everion® second

A CORE® device will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear it all the time, with exception of the time needed for battery charging and the patients' hygiene. Then two Everion® devices, one for the day and one for the night, to be switched every morning and evening, 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: Everion®; Device: CORE®

Everion® and CORE® simultaneously

Two Everion® devices, one for the day and one for the night, to be switched every morning and evening, and one CORE® 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: Everion®; Device: CORE®

Interventions

Everion® DEVICE

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® first, Everion® second; Everion® and CORE® simultaneously; Everion® first, CORE® second; Everion® only

CORE® DEVICE

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.

CORE® first, Everion® second; CORE® only; Everion® and CORE® simultaneously; Everion® first, CORE® second

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients undergoing chemotherapy for cancer treated in the departments of pediatric oncology at the Children's university hosptials Bern or Basel.

You may qualify if:

• 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

You may not qualify if:

• Local skin diseases prohibiting wearing of the WD.
• Denied written informed consent from participants

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (2)

University Children's Hospital Basel, University of Basel

Basel, Switzerland

Location

Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Koenig C, Ammann RA, Schneider C, Wyss J, Roessler J, Brack E. Continuous timely monitoring of core temperature with two wearable devices in pediatric patients undergoing chemotherapy for cancer - a comparison study. Support Care Cancer. 2024 Feb 24;32(3):188. doi: 10.1007/s00520-024-08366-w.

  PMID: 38400942 DERIVED

MeSH Terms

Conditions

Neoplasms; Febrile Neutropenia

Condition Hierarchy (Ancestors)

Neutropenia; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Eva Brack, MD, PhD

  Pediatric Hematology/Oncology, Inselspital, Bern University Hospital

  PRINCIPAL INVESTIGATOR

• Christa Koenig, MD

  Pediatric Hematology/Oncology, Inselspital, Bern University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 7, 2021
• Study Start: September 16, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After publication of the study results, no time limitation after publication.
• Access Criteria: Open Access

Locations

CH (2)