Symptoms and General Pathology

Wounds and Injuries

All Conditions

Blood and Lymph Conditions

Rare Diseases

Hyperthermia

Neutropenia

Fever

Febrile Neutropenia

Agranulocytosis

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Granulocytopenia

The Everion® 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.

The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

Everion

Eva Brack, MD-PhD

Christa Koenig, MD

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.

No study has proved feasibility of continuous monitoring of health data with a small wearable device such as the device Everion® in pediatric patients. It is not known if children tolerate the device and if data quality sustains with smaller arm circumferences or when worn on the upper leg. Neither is it known if parents and/or patients can and are willing to handle the device in ambulant setting. Therefore, this pilot study assesses 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.

Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy

Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study

The coded study data (from the WD and clinical data) will be uploaded to figshare and made publically available for other researchers.

The primary outcome is defined as at least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable (≥50) quality score (worst quality 0, best quality 100) of oxygen saturation during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable(≥50) quality score (worst quality 0, best quality 100) of respiration rate during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable(≥50) quality score (worst quality 0, best quality 100) of core temperature during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable (≥50) quality score (worst quality 0, best quality 100) of heart rate variability during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

At least acceptable (≥50) quality score (worst quality 0, best quality 100) of perfusion index during a cumulative duration of ≥18/24h per day (noon to noon), during ≥7 consecutive days within the 14 days of study duration (binary outcome, measured once).

Cumulative length of time with monitored heart rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored oxygen saturation with at least acceptable quality score (≥50 worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored respiration rate with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored core temperature with at least acceptable quality score (≥50, worst quality 0, best quality 100)) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored heart rate variability with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Cumulative length of time with monitored perfusion index with at least acceptable quality score (≥50, worst quality 0, best quality 100) per study day (continuous outcomes, measured daily).

Proportion of patients and parents indicating that continuous monitoring with the wearable device (WD) is acceptable per day and per entire study duration and reasons not to wear the device.

Number and description of side effects reported by parents and patients, if applicable. Assessed with questionnaires.

Effort (cumulative number of contacts) for the Investigators.

Effort (cumulative duration of contacts) for the Investigators.

Difference between discrete measurements performed for clinical routine cares of heart rate and the mean of continuously measured heart rate within +/-10min at times of the discrete measurement.

Exploration of potential changes in or specific patterns of all collected signals and their quality scores in combination (heart rate, oxygen saturation, respiration rate, core temperature, skin temperature, heart rate variability, perfusion index, health score (0-100, higher score means better health), galvanic skin response) , within 48 hours before and after clinical diagnosis of fever (ear temperature of ≥39.0°C, or ≥38.5°C if fever is declared for clinical reasons) with or without neutropenia and microbiologically or clinically defined infections, if applicable.

Insel Gruppe AG, University Hospital Bern

The Everion® 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.

Everion: The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.

Everion®

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Switzerland

Region of Enrollment

Acute lymphoblastic leukemia

Other hematologic malignancies

Central nervous system tumor

Solid tumor

Type of malignancy

(i) The WDs were studied for only 14 days and compliance might be different during long-term use.

(ii) The small number of patients precluded an analysis of patient factors (iii) The planned comparison of discrete measurements versus continuously was not feasible because the exact second-wise time point of discrete measurements was not available.

Dr. med. Christa König

Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)

Continous Monitoring of Oxygen Saturation With the WD

Continous Monitoring of Respiration Rate With the WD

Continous Monitoring of Core Temperature With the WD

Continous Monitoring of Heart Rate Variability With the WD

Continous Monitoring of Perfusion Index With the WD

Cumulative Time of Monitoring Heart Rate With the WD

Cumulative Time of Monitoring Oxygen Saturation With the WD

Cumulative Time of Monitoring Respiration Rate With the WD

Cumulative Time of Monitoring Core Temperature With the WD

Cumulative Time of Monitoring Heart Rate Variability With the WD

Cumulative Time of Monitoring Perfusion Index With the WD

Device Acceptance Assessed With Questionnaires

Superficial skin lesion

irritated skin

itching

sweating

Number and Description of Side Effects

Effort for Investigators Assessed by Number of Contacts

Effort for Investigators Assessed by Duration of Contacts

The analysis of differences between discrete measurements and continuously recorded aggregates of vital signs, as defined in the protocol, was found to yield massively distorted results because rapidly changing discretely measured vital signs were compared to aggregated means covering up to 20 min. We deliberately refrain from displaying these nonmeaningful results here.

Comparison

Episodes with fever

Episodes with Infection

The 4 episodes occured in 3 of these 20 patients. The other 17 patients had no episode with fever or infection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy	NCT04134429	Pediatric Cance... Febrile Neutrop... Chemotherapy-in... Oncology	Everion	1 Month - 17 Years	Insel Gruppe AG, University Hospital Bern
Feasibility of Monitoring Health Data in Pediatric Patients Undergoing Chemotherapy	NCT04134429	Pediatric Cance... Febrile Neutrop... Chemotherapy-in... Oncology	Everion	1 Month - 17 Years	Insel Gruppe AG, University Hospital Bern

Spots Global Cancer Trial Database for everion®

Every month we try and update this database with for everion® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for everion®

Every month we try and update this database with for everion® cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for everion® cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.