Evaluation of Sibel’s Advanced Neonatal Epidermal (ANNE) wireless continuous physiological monitor in Nairobi, Kenya

Authors

Jesse Coleman, Evaluation of Technologies for Neonates in Africa, Kenya
Amy Sarah Ginsburg, University of Washington, USA
William Macharia, Aga Khan UniversityFollow
Roseline Ochieng, Aga Khan UniversityFollow
Dorothy Chomba, Aga Khan UniversityFollow
Guohai Zhou, Brigham and Women’s Hospital, USA
Dustin Dunsmuir, University of British Columbia, Canada
Shuai Xu, Northwestern University, USA
J. Mark Ansermino, University of British Columbia, Canada

Document Type

Article

Department

Paediatrics and Child Health (East Africa)

Abstract

Background: Neonatal multiparameter continuous physiological monitoring (MCPM) technologies assist with early detection of preventable and treatable causes of neonatal mortality. Evaluating accuracy of novel MCPM technologies is critical for their appropriate use and adoption.

Methods: We prospectively compared the accuracy of Sibel’s Advanced Neonatal Epidermal (ANNE) technology with Masimo’s Rad-97 pulse CO-oximeter with capnography and Spengler’s Tempo Easy reference technologies during four evaluation rounds. We compared accuracy of heart rate (HR), respiratory rate (RR), oxygen saturation (SpO₂), and skin temperature using Bland-Altman plots and root-mean-square deviation analyses (RMSD). Sibel’s ANNE algorithms were optimized between each round. We created Clarke error grids with zones of 20% to aid with clinical interpretation of HR and RR results.

Results: Between November 2019 and August 2020 we collected 320 hours of data from 84 neonates. In the final round, Sibel’s ANNE technology demonstrated a normalized bias of 0% for HR and 3.1% for RR, and a non-normalized bias of -0.3% for SpO₂ and 0.2°C for temperature. The normalized spread between 95% upper and lower limits-of-agreement (LOA) was 4.7% for HR and 29.3% for RR. RMSD for SpO₂ was 1.9% and 1.5°C for temperature. Agreement between Sibel’s ANNE technology and the reference technologies met the a priori-defined thresholds for 95% spread of LOA and RMSD. Clarke error grids showed that all HR and RR observations were within a 20% difference.

Conclusion: Our findings suggest acceptable agreement between Sibel’s ANNE and reference technologies. Clinical effectiveness, feasibility, usability, acceptability, and cost-effectiveness investigations are necessary for large-scale implementation.

Publication (Name of Journal)

PLoS ONE

Recommended Citation

Coleman, J., Ginsburg, A. S., Macharia, W., Ochieng, R., Chomba, D., Zhou, G., Dunsmuir, D., Xu, S., Ansermino, J. M. (2022). Evaluation of Sibel’s Advanced Neonatal Epidermal (ANNE) wireless continuous physiological monitor in Nairobi, Kenya. PLoS ONE, 17(6), 1-14.
Available at: https://ecommons.aku.edu/eastafrica_fhs_mc_paediatr_child_health/196

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.