Abstract
PurposePediatric 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.MethodsIn 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.ResultsTwenty 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.ConclusionThe 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 registrationClinicalTrials.gov (NCT04134429) on October 22, 2019.
Highlights
Pediatric patients with cancer and chemotherapy-induced neutropenia are at high risk of potentially life-threatening infections
This study aimed to assess the feasibility of continuous multiparameter recording of vital signs in pediatric patients undergoing chemotherapy for cancer using a wearable device (WD); to assess feasibility in preschool patients; to compare continuously recorded vital signs with discrete measurements performed during clinical routine care; and to explore vital signs for specific patterns detectable before episodes of fever and infection
On 142 of 274 days (52%; 95% confidence interval (CI) 46 to 59%), heart rate was recorded in good quality on ≥18/24 hours per day
Summary
Pediatric patients with cancer and chemotherapy-induced neutropenia are at high risk of potentially life-threatening infections. Fever is often the only clinical detectable sign of such an Christa Koenig and Roland A. Fever in neutropenia is treated as an emergency, leading to hospitalization, start of intravenous empirical broad-spectrum antibiotics, and close monitoring [1]. Delay of diagnosis and treatment may result in more intensive treatment, more adverse events, and increased mortality [2,3,4]. Longer time between hospital admission and start of antibiotics seems to be associated with worse outcomes [5]. Several clinical decision rules help to distinguish between severe and less severe infections [6,7,8], but with the exception of fever, they do not rely on vital signs
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