The measurement of vital signs in pediatric patients by Lifelight® software in comparison to the standard of care: the VISION-Junior observational study protocol (Preprint)

BACKGROUND Measuring vital signs (VS) is important in potentially unwell children, as a change in VS may indicate a more serious infection than is clinically apparent or herald clinical deterioration. However, currently available methods are not suitable for regular measurement of VS in the home or community setting, and adherence can be poor. The COVID-19 pandemic highlighted a need for the contactless measurement of VS by non-clinical personnel, reinforced by the growing use of virtual medicine. Lifelight® is an app being developed as a medical device for the contactless measurement of VS using remote photoplethysmography via the camera on smart devices. The VISION-D (Measurement of Vital Signs by Lifelight® Software in Comparison to the Standard of Care – Development) and -V (Validation) studies demonstrated the accuracy of Lifelight compared with standard of care measurement of blood pressure, pulse rate, and respiratory rate in adults, supporting certification of Lifelight as a class I Conformité Européenne (CE) medical device. OBJECTIVE To support further development of the Lifelight app, the VISION-Junior study (clinicaltrials.gov identifier NCT05850013) is collecting high-quality data to enable the accurate measurement of VS (pulse rate, respiratory rate and oxygen saturation) in pediatric patients. METHODS The study is recruiting pediatric patients (age <18 years) attending the Sunderland Royal Hospital Paediatric Emergency Department of the South Tyneside and Sunderland NHS Foundation Trust. High-resolution videos of the face (and torso in children aged <5 years) and audio recordings (to explore the value of cry, wheeze, cough, and other sounds in predicting illness) are made using the Lifelight Data Collect app. VS are measured simultaneously using standard of care methods (finger clip sensor for pulse rate and oxygen saturation; manual counting of respiratory rate). Feedback from patients, parents/carers, and nurses who use Lifelight is collected via questionnaires. Anticipated recruitment is 500 participants, with sub-targets for age, sex, and skin tone distribution (Fitzpatrick six-point scale). Early data will be used to refine the Lifelight algorithms. A separate dataset will be retained to test the performance of Lifelight against predefined targets. RESULTS A total of 303 participants were recruited from June to December 2023; recruitment will continue until March 2024. Algorithm refinement is in progress. The performance of Lifelight compared with standard of care measurement of VS will then be tested. Recruitment will resume if further data are required. The analyses are expected to be completed by mid-April 2024. CONCLUSIONS This study will collect data that enable development of Lifelight for the measurement of VS in pediatric patients. CLINICALTRIAL ClinicalTrials.gov NCT05850013 https://clinicaltrials.gov/study/NCT05850013