Continuous recording of vital signs with a wearable device in pediatric patients undergoing chemotherapy for cancer-an operational feasibility study

Abstract

Purpose: 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.

Methods: 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.

Results: 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.

Conclusion: 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.

Trial registration: ClinicalTrials.gov (NCT04134429) on October 22, 2019.

Keywords: Continuous recording; Pediatric oncology; Recording vital signs; Supportive care; Wearable device.

Fig. 1

The Everion® device, placed on the upper leg of a 10-month-old and on the upper arm of a 3-year-old child. (Parents gave informed consent for publication of these photographs)

Fig. 2

a Primary outcome measure—recording of heart rate. b Recording of heart rate variability. Legend: green, good data quality; red, poor data quality; white, no data recorded; gray, no study days; days ≥18 h, number of days with at least 18 hours of good data quality per patient; ID, patient ID

Fig. 3

Histogram and quality assignment of heart rate, plus proportion of time with poor quality assignment of heart rate variability according to heart rate

Fig. 4

Histogram and quality assignment of respiration rate. Legend: green, good data quality; red, poor data quality

Fig. 5

Histogram and quality assignment of core temperature (calculated). Legend: green, good data quality; red, poor data quality