Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 10, 2019
Date Accepted: Oct 21, 2020
Developing the accuracy of vital signs measurements by the LifelightTM software application in comparison to standard of care methods: an observational study protocol
ABSTRACT
Background:
Vital sign measurements are an integral component of clinical care, but current challenges with the accuracy and timeliness of patient observations can impact appropriate clinical decision making. Advanced technologies using techniques such as photoplethysmography have the potential to automate non-contact physiological monitoring and recording, improving the quality and accessibility of this essential clinical information.
Objective:
To develop the algorithm used in the LifelightTM software application and improve the accuracy of its estimated heart rate, respiratory rate, oxygen saturation and blood pressure measurements
Methods:
This preliminary study will compare measurements predicted by the LifelightTM software with standard of care measurements for a population sample of 2000 inpatients, outpatients and healthy people attending a large acute hospital. Both training datasets and validation datasets will be analysed to assess the degree of correspondence between the vital sign measurements predicted by the LifelightTM software and the direct physiological measurements taken using standard of care methods. Sub group analyses will explore how the performance of the algorithm varies with particular patient characteristics, including age, sex, health condition and medication.
Results:
Recruitment of participants to this study began in July 2018 and data collection will continue for a planned study period of 12 months.
Conclusions:
Digital health technology is a rapidly evolving area for health and social care. Following this initial exploratory study to develop and refine the LifelightTM software application, subsequent work will evaluate its performance across a range of health characteristics and extended validation trials will support its pathway to registration as a medical device. Innovations in health technology such as this may provide valuable opportunities for increasing the efficiency and accessibility of vital sign measurements and improve healthcare services on a large scale across multiple health and care settings.
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