Pediatric Hematology/Oncology, Department of Pediatrics, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland.
Kinderaerzte KurWerk, Burgdorf, Switzerland.
Support Care Cancer. 2021 Sep;29(9):5283-5292. doi: 10.1007/s00520-021-06099-8. Epub 2021 Mar 3.
Pediatric patients with cancer are at high risk for severe infections. Infections can trigger changes of vital signs long before clinical symptoms arise. Continuous recording may detect such changes earlier than discrete measurements. We aimed to assess the feasibility of continuous recording of vital signs by a wearable device (WD) in pediatric patients undergoing chemotherapy for cancer.
In this prospective, observational single-center study, pediatric patients under chemotherapy wore the Everion® WD for 14 days. The predefined patient-specific goal was heart rate recorded in good quality during ≥18/24 h per day, on ≥7 consecutive days. The predefined criterion to claim feasibility was ≥15/20 patients fulfilling this patient-specific goal.
Twenty patients were included (median age, 6 years; range, 2-16). Six patients aged 3-16 years fulfilled the patient-specific goal. Quality of heart rate recording was good during 3992 of 6576 (61%) hours studied and poor during 300 (5%) hours, and no data was recorded during 2284 (35%) hours. Eighteen of 20 participants indicated that this WD is acceptable to measure vital signs in children under chemotherapy.
The predefined feasibility criterion was not fulfilled. This was mainly due to important compliance problems and independent of the WD itself. However, continuous recording of vital signs was possible across a very wide age range in pediatric patients undergoing chemotherapy for cancer. We recommend to study feasibility in the Everion® again, plus in further WDs, applying measures to enhance compliance.
ClinicalTrials.gov (NCT04134429) on October 22, 2019.
患有癌症的儿科患者存在发生严重感染的高风险。感染可在临床症状出现之前很久引发生命体征的变化。连续记录可能比离散测量更早地检测到这些变化。我们旨在评估可穿戴设备（WD）在接受癌症化疗的儿科患者中连续记录生命体征的可行性。
在这项前瞻性、观察性的单中心研究中，接受化疗的儿科患者佩戴 Everion® WD 14 天。预定义的患者特定目标是记录≥18/24 小时/天，连续≥7 天的高质量心率。满足该患者特定目标的患者≥15/20 例是声称可行性的预定义标准。
共纳入 20 例患者（中位年龄 6 岁；范围 2-16 岁）。6 例 3-16 岁的患者达到了患者特定的目标。研究期间，3992/6576（61%）小时的心率记录质量良好，300/6576（5%）小时记录质量差，2284/6576（35%）小时未记录数据。20 名参与者中的 18 名表示该 WD 可接受用于测量接受化疗的儿童的生命体征。
未满足预定义的可行性标准。这主要是由于依从性问题严重，与 WD 本身无关。然而，在接受癌症化疗的儿科患者中，连续记录生命体征是可行的，年龄范围非常广泛。我们建议在 Everion®中再次研究可行性，并在其他 WD 中应用提高依从性的措施。
ClinicalTrials.gov（NCT04134429）于 2019 年 10 月 22 日。
