Measurement of Vital Signs by Lifelight Software in Comparison to Standard of Care Multisite Development (VISION-MD): Protocol for an Observational Study

Abstract

BackgroundMeasuring vital signs (VS) is an important aspect of clinical care but is time-consuming and requires multiple pieces of equipment and trained staff. Interest in the contactless measurement of VS has grown since the COVID-19 pandemic, including in nonclinical situations. Lifelight is an app being developed as a medical device for the contactless measurement of VS using remote photoplethysmography (rPPG) 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 VISION-V (Validation) studies demonstrated the accuracy of Lifelight compared with standard-of-care measurement of blood pressure, pulse rate, and respiratory rate, supporting the certification of Lifelight as a class I Conformité Européenne (CE) medical device. ObjectiveTo support further development of the Lifelight app, the observational VISION Multisite Development (VISION-MD) study is collecting high-quality data from a broad range of patients, including those with VS measurements outside the normal healthy range and patients who are critically ill. MethodsThe study is recruiting adults (aged ≥16 years) who are inpatients (some critically ill), outpatients, and healthy volunteers, aiming to cover a broad range of normal and clinically relevant VS values; there are no exclusion criteria. High-resolution 60-second videos of the face are recorded by the Lifelight app while simultaneously measuring VS using standard-of-care methods (automated sphygmomanometer for blood pressure; finger clip sensor for pulse rate and oxygen saturation; manual counting of respiratory rate). Feedback from patients and nurses who use Lifelight is collected via a questionnaire. Data to estimate the cost-effectiveness of Lifelight compared with standard-of-care VS measurement are also being collected. A new method for rPPG signal processing is currently being developed, based on the identification of small areas of high-quality signals in each individual. Anticipated recruitment is 1950 participants, with the expectation that data from approximately 1700 will be used for software development. Data from 250 participants will be retained to test the performance of Lifelight against predefined performance targets. ResultsRecruitment began in May 2021 but was hindered by the restrictions instigated during the COVID-19 pandemic. The development of data processing methodology is in progress. The data for analysis will become available from September 2022, and the algorithms will be refined continuously to improve clinical accuracy. The performance of Lifelight compared with that of the 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 in early 2023. ConclusionsThis study will support the refinement of data collection and processing toward the development of a robust app that is suitable for routine clinical use. Trial RegistrationClinicalTrials.gov NCT04763746; https://clinicaltrials.gov/ct2/show/NCT04763746 International Registered Report Identifier (IRRID)DERR1-10.2196/41533