Comparing the Garmin Venu 3 / Garmin Venu 4 for Non-Invasive Vital Sign Monitoring to a Hospital-Grade Monitor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZiekenhuis Oost-Limburg
About this trial
This clinical trial evaluates the accuracy of the Garmin Venu 3 / Garmin Venu 4 smartwatch in measuring vital signs (heart rate, respiratory rate, SpO₂) compared to the clinically validated Philips IntelliVue X2. The study aims to determine whether the consumer-grade smartwatch can provide reliable data for remote patient monitoring, early hospital discharge, and chronic disease management, offering a more accessible and affordable alternative to MDR-certified devices.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide signed and dated informed consent
Adults older than 18 years of age
Speak and understand the Dutch language
Hospitalized for at least another 24 hours
Disqualifiers
Life expectancy is less than 30 days
Patient is isolated due to infection control
Trial design
Design model
Single group
Treatments tested in this trial
Garmin Venu 3 or Garmin Venu 4 + Philips Intellivue X2
DeviceEach participant will be continuously monitored for a minimum of one full night and up to a maximum of 24 hours using both a hospital-grade monitor (Philips IntelliVue X2) and a Garmin Venu 3 or Garmin Venu 4 smartwatch.
Smartwatch rating scale questionnaire
Other interventionUpon completion of the monitoring period, participants will be asked to complete the Smartwatch Rating Scale (SRS) questionnaire
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Patients admitted to the pulmonology wardExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring heart rate up to 24 hours.
For heart rate, the mean absolute difference will be calulated between the measurements performed with the Garmin Venu 3 / Garmin Venu 4 and the measurements performed with the Philips Intellivue X2
Time frame
From enrollment to the end of treatment at 24 hours2
Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring respiratory rate up to 24 hours.
For respiratory rate, the mean absolute difference will be calculated between the measurements performed with the Garmin Venu 3 / Garmin Venu 4 and the measurements performed with the Philips IntelliVue X2
Time frame
From enrollment to the end of treatment at 24 hours3
Mean absolute difference between the Garmin Venu 3 / Garmin Venu 4 and a hospital-grade monitor in measuring peripheral oxygen saturation up to 24 hours.
For peripheral oxygen satuation (SpO2), the mean absolute difference will be calculated between the measurements performed with the Garmin Venu 3 / Garmin Venu 4 and the measurements performed with the Philips IntelliVue X2.
Time frame
From enrollment to the end of treatment at 24 hoursSecondary outcomes
1
User experience of the Garmin Venu 3 / Garmin Venu 4 as measured by the Smartwatch Rating Scale
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 hours2
Number of artefacts during measurements performed when the participant is awake vs measurements performed when the participant is asleep (expressed in % measurements)
Measurements reported as a '0' due to the inability of the device to perform a correct measurement will be labeled as false.
Time frame
From enrollment to the end of treatment at 24 hours3
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
In the event of patient deterioration, changes may be reflected in SpO2 levels. This endpoint will evaluate the time taken by the Garmin Venu 3 / Garmin Venu 4 compared to a hospital-grade monitor to detect such changes.
Time frame
From enrollment to the end of treatment at 24 hoursSponsors and contacts
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Source ClinicalTrials.gov