Respiratory monitoring and apnoea detection in paediatric and neonatal patients using a wearable accelerometer-based chest sensor: protocol for an observational diagnostic feasibility study.

INTRODUCTION

Accurate evaluation of respiratory rate and pattern is important in health and disease; however, it can be challenging in children and babies due to small size and poor tolerability of existing monitoring equipment. This protocol outlines a study evaluating the feasibility of collecting respiratory data using a chest-worn accelerometer-based motion sensor in paediatric patients at risk of apnoea, respiratory failure and sudden death.

METHODS AND ANALYSIS

This is an observational feasibility study over a 2-year period. The biosensor is an accelerometer worn on an ECG electrode during standard care at the Royal Hospital for Children, Glasgow. We aim to recruit three groups of patients (75 patients to each group): (1) Children attending for overnight cardiorespiratory polygraphy (0 to ≤16 years), (2) neonatal inpatients (from 30 weeks gestation) and (3) children attending for video telemetry at the epilepsy monitoring unit (0 to ≤16 years). Measurements will include (1) chest and/or abdominal wall motion measured by the worn biosensors; (2) standard clinical monitoring data will be collected to support biosensor data interpretation and (3) acceptability will be measured by a feedback questionnaire completed by patients and their parents/guardians.

ETHICS AND DISSEMINATION

This study protocol was reviewed and approved by Yorkshire and The Humber-Leeds East Research Ethics Committee, approval number 314 696. This study involves human participants; written informed consent and assent, when appropriate, will be obtained from participants (or their parent/legal guardian/next of kin) to participate in the study. The study will be carried out in accordance with the World Medical Association Declaration of Helsinki (1964) standard reporting. Study findings will be reported clearly and transparently with relevant stakeholders including researchers, practitioners and publicly available databases. Results from this study will be presented at national and international conferences and reported in peer-reviewed publications.

TRIAL REGISTRATION NUMBER

NCT06292299 pre-results stage.