Comparing the Garmin Venu 3 / Garmin Venu 4 for Non-Invasive Vital Sign Monitoring to a Hospital-Grade Monitor

Wearable technology has rapidly evolved from fitness tracking tools to potential clinical-grade devices capable of non-invasive monitoring of vital signs. Among these, smartwatches equipped with optical sensors and accelerometers now offer continuous measurements of parameters such as heart rate, respiratory rate, and blood oxygen saturation (SpO2). The Garmin Venu 3 / Garmin Venu 4 represent a new generation of commercially available smartwatches that provide vital sign monitoring outside of controlled medical environments.

Despite their growing popularity and technological advancements, the clinical validity of smartwatches remains unknown. Applying for medical device regulation (MDR) certification is a long and expensive process, something not all companies can or want to invest in. Besides, the devices that are MDR certified are often very expensive, something not possible to use in an average patient population without extensive funding. For the use of (non-MDR certified) smartwatches into clinical workflows or remote patient monitoring systems, these devices must demonstrate accuracy and reliability comparable to gold-standard hospital-grade monitors.

The Philips IntelliVue X2 is a widely used and clinically validated multi-parameter patient monitoring system employed in acute care setting. It provides high-fidelity, real-time monitoring of vital signs and serves as an appropriate benchmark for evaluating the performance of customer-grade devices.

Comparing measurements obtained with the Garmin Venu 3 / Garmin Venu 4 against the IntelliVue X2 is essential to determine whether the smartwatch can serve as a reliable tool for continuous vital sign tracking in real-world clinical scenarios. This is particularly relevant for use cases such as early hospital discharge, remote patient monitoring and chronic disease management where accessibility, affordability, convenience and user compliance are critical.

This clinical trial seeks to assess the agreement and accuracy of the Garmin Venu 3 / Garmin Venu 4 in measuring key physiological parameters such as heart rate, respiratory rate, and SpO2 compared to the Philips Intellivue X2 in a diverse patient population. Demonstrating clinical equivalence or acceptable accuracy margins would support the potential use of the Garmin Venu 3 / Garmin Venu 4 in remote or supplemental monitoring roles within modern (hybrid) healthcare systems.

• User experience of the Garmin Venu 3 / Garmin Venu 4 as measured by the Smartwatch Rating Scale [Time frame: From enrollment to the end of treatment at 24 hours]
• Number of artefacts during measurements performed when the participant is awake vs measurements performed when the participant is asleep (expressed in % measurements) [Time frame: From enrollment to the end of treatment at 24 hours]
• Time to detection of a sudden drop in SpO2 or clinical deterioration measured by the Garmin Venu 3 / Garmin Venu 4 vs a hospital-grade monitor [Time frame: From enrollment to the end of treatment at 24 hours]