JMIR Publications

ABSTRACT

Background:

Over 10 million newborns in a year worldwide undergo resuscitation at birth. Pediatricians may use electrocardiogram (ECG), pulse oximetry (PO), and stethoscope in determining heart rate (HR), as HR guides the need for and steps of resuscitation. HR must be obtained quickly and accurately. Unfortunately, the current diagnostic modalities are either too slow, obtaining HR in more than a minute, or inaccurate. With time constraints, a reliable robust heart rate device (HRD) modality is required. This paper discusses a protocol for conducting a methods-based comparison study to determine HR accuracy of a novel real-time HRD based on 3D printed dry electrode single-lead ECG signals. The HRD’s HR results are compared to either clinical grade ECG or PO monitors.

Objective:

The purpose of this study is to design and examine the feasibility of a proof-of-concept HRD that quickly obtains HR using biocompatible 3D printed dry electrodes for single-lead neonatal ECG acquisition and compare it to the gold-standard 3-lead clinical ECG and/or POs in a hospital setting.

Methods:

A cross-sectional study is planned to be conducted in the Neonatal Intensive Care Unit (NICU) or Post-Partum Unit (PPU) at a large community teaching hospital in Toronto Canada from June 2023 to June 2024. In total 50 newborns will be recruited for this study. The HRD and an ECG or PO monitor will be video recorded using a digital camera concurrently for 3 minutes for each newborn. Hardware-based signal processing and HR estimations techniques are applied directly to the raw collected single-lead ECG and displayed on the HRD in real-time during video recordings. This data will be annotated and compared to the ECG or PO readings at the same points in time.

Results:

The study received research ethics boards’ approvals in April 2023 and June 2023. The study is ongoing.

Conclusions:

The study will compare the patent-pending 3D printed dry electrode-based novel HRD’s real-time HR estimation techniques with state-of-the-art clinical grade ECG or PO monitors for HR accuracy and how fast it provides reliable HR. The study will further provide recommendations and important improvements that can be made to implement the HRD for clinical applications especially in neonatal resuscitation efforts.