Continuous Monitoring of Health Data With a Wearable Device in Pediatric Patients Undergoing Chemotherapy for Cancer - a Feasibility Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Local skin diseases prohibiting wearing of the device.
- •Denied written informed consent from patients and/or parent
结局指标
主要结局
Feasibility of Continous Monitoring of Heart Rate With the Wearable Device (WD)
时间窗: 14 days
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).
次要结局
- Continous Monitoring of Heart Rate Variability With the WD(14 days)
- Continous Monitoring of Perfusion Index With the WD(14 days)
- Cumulative Time of Monitoring Heart Rate With the WD(14 days)
- Number and Description of Side Effects(14 days)
- Continous Monitoring of Oxygen Saturation With the WD(14 days)
- Effort for Investigators Assessed by Duration of Contacts(14 days)
- Continous Monitoring of Respiration Rate With the WD(14 days)
- Comparison(14 days)
- Continous Monitoring of Core Temperature With the WD(14 days)
- Cumulative Time of Monitoring Oxygen Saturation With the WD(14 days)
- Cumulative Time of Monitoring Respiration Rate With the WD(14 days)
- Cumulative Time of Monitoring Core Temperature With the WD(14 days)
- Cumulative Time of Monitoring Heart Rate Variability With the WD(14 days)
- Cumulative Time of Monitoring Perfusion Index With the WD(14 days)
- Device Acceptance Assessed With Questionnaires(14 days)
- Effort for Investigators Assessed by Number of Contacts(14 days)
- Exploration of Patterns Within the Vital Signs Before Episodes With Fever or Infection(14 days)