N/A
Completed N=20
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy
Source: ClinicalTrials.gov NCT04134429 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2021
Primary outcomePrimary: Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD) — 6 Participants
Summary
In this pilot study the feasibility of continous monitoring of health data with a small, on-skin wearable device (the Everion®, by Biovotion, Zurich) in pediatric patients under chemotherapy for cancer, is studied. Feasibility is assessed by the number of patients wearing the device on seven consecutive days for at least 18h/day, what will be measured by monitored heart rate. Study duration for each participant is 14 days.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD) |
6 | — |
| SECONDARY Continous Monitoring of Oxygen Saturation With the WD |
— | — |
| SECONDARY Continous Monitoring of Respiration Rate With the WD |
4 | — |
| SECONDARY Continous Monitoring of Core Temperature With the WD |
6 | — |
| SECONDARY Continous Monitoring of Heart Rate Variability With the WD |
1 | — |
| SECONDARY Continous Monitoring of Perfusion Index With the WD |
6 | — |
| SECONDARY Cumulative Time of Monitoring Heart Rate With the WD |
3992 | — |
| SECONDARY Cumulative Time of Monitoring Oxygen Saturation With the WD |
1103 | — |
| SECONDARY Cumulative Time of Monitoring Respiration Rate With the WD |
4058 | — |
| SECONDARY Cumulative Time of Monitoring Core Temperature With the WD |
4037 | — |
| SECONDARY Cumulative Time of Monitoring Heart Rate Variability With the WD |
3142 | — |
| SECONDARY Cumulative Time of Monitoring Perfusion Index With the WD |
3992 | — |
| SECONDARY Device Acceptance Assessed With Questionnaires |
18 | — |
| SECONDARY Number and Description of Side Effects |
1; 4; 3; 7 | — |
| SECONDARY Effort for Investigators Assessed by Number of Contacts |
52 | — |
| SECONDARY Effort for Investigators Assessed by Duration of Contacts |
390 | — |
| SECONDARY Comparison |
— | — |
| SECONDARY Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection |
3; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Chemotherapy treatment because of any malignancy, expected to last ≥1 months at time of recruitment for myelosuppressive therapy or at least one cycle of myeloablative therapy.
- Age 1 month to <18 years at time of recruitment
- Written informed consent from patients and/or parents
Exclusion Criteria
- Local skin diseases prohibiting wearing of the device.
- Denied written informed consent from patients and/or parent
Data sourced from ClinicalTrials.gov (NCT04134429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.