Continuous Monitoring of Vital Signs With Different Wearable Devices in Pediatric Patients Undergoing Chemotherapy for Cancer - a Comparison and 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
- 2
- 主要终点
- Feasibility of continous recording of core temperature with the two wearable devices (WDs)
研究概览
简要总结
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.
详细描述
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.
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 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
排除标准
- •Local skin diseases prohibiting wearing of the WD.
- •Denied written informed consent from participants
结局指标
主要结局
Feasibility of continous recording of core temperature with the two wearable devices (WDs)
时间窗: 14 days
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.
次要结局
- Feasibility of continous recording of respiration rate with the Everion®(14 days)
- Feasibility of continous recording of heart rate variability 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)
- Feasibility of continous recording of heart rate with the Everion®(14 days)
- Cumulative time of monitoring heart rate variability with the Everion®(14 days)
- Effort for investigators assessed by duration of contacts(14 days)
- Acceptability of CORE®(14 days)
- Data arrival on the dashboard for core temperature (CORE®)(14 days)
- Cumulative time of monitoring respiration rate with the Everion®(14 days)
- Data arrival on the dashboard for core temperature (Everion®)(14 days)
- Effort for investigators assessed by number of contacts(14 days)
- Acceptability of Everion®(14 days)
- Side Effects(14 days)
- User-friendliness(14 days)
- Comparison of core temperature with discrete measurements(14 days)
- Exploration(14 days)