Validation of Pulse Oxygen Saturation, Heart Rate, Blood Pressure and Respiratory Rate raised by a Contactless Telehealth Portal: Validation Study.

BACKGROUND: The traditional measurement of these vitals via physical examination has become challenging and the recent pandemic has accelerated trends towards telehealth and remote monitoring. Instead of going to the physician for checking Heart Rate, Oxygen Saturation (SPO2), Blood Pressure, Body Temperature and Respiration Rate it would be excellent if it could be measured at home. Vital signs monitors, also known as physiological parameter monitors, are electronic devices that measure and display biological information about patients under constant monitoring.

OBJECTIVE: The purpose of this study was to validate the accuracy of the Pulse Oxygen Saturation, Heart Rate, Blood Pressure and Respiratory Rate of Docsun Telehealth by comparing it with approved medical devices.

METHODS: This is a non-invasive self-check system-based study which was conducted to validate the detection of vital signs (Pulse Oxygen Saturation, Heart Rate, Blood Pressure and Respiratory Rate) raised by the Docsun Telehealth Portal. The input for the software processing is a facial screening without any accessories on the face, directly scanning through the software application portal. The subject's facial features are detected and screened for the extraction of necessary reading.

RESULTS: For the HR, SPO2, BP and RR measurement validation, the main outcome was the mean of the absolute difference between the respective investigational devices and the reference values and the percent absolute difference between the respective investigational devices and the reference values. If the HR was within ±10% of the reference standard or 5 beats/min, it was considered to be acceptable for clinical purposes. The average absolute difference between the Docsun Telehealth Portal and the reference values was 1.41 bpm. The mean absolute percentage difference was 1.69%. The Docsun Telehealth Portal therefore met the predefined accuracy cutoff for HR measurements. If the RR was within ±10% of the reference standard or 3 breaths/min, it was considered to be acceptable for clinical purposes. The average absolute difference between the Docsun Telehealth Portal was 0.86 breaths/minute. The absolute percentage difference was 4.72%. The Docsun Telehealth Portal therefore met the predefined accuracy cutoff for RR measurements. SPO2 levels were considered acceptable if the average absolute difference between the Docsun Telehealth Portal and the reference values was ±3%. The mean absolute percentage difference was 0.59%. The Docsun Telehealth Portal therefore met the predefined accuracy cutoff for SPO2 measurements. The Docsun Telehealth Portal predicted systolic BP with an accuracy of 94.81% and diastolic BP with an accuracy of 95.71%.

CONCLUSIONS: The results of the study shows that the accuracy of the Heart Rate, Blood Pressure, SPO2 and Respiratory Rate values raised by the Docsun Telehealth Portal compared against the clinically approved medical device proved to be accurate by meeting the predefined accuracy guidelines.