Wearable Blood-Pressure Monitoring Comparison Study
Recruiting · NCT07719660 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →What this trial is about
The goal of this clinical trial is to compare the accuracy, clinical applicability, and usability of different wearable blood pressure monitoring methods integrated in wearable devices, such as smartwatches, in hospitalized patients. The study evaluates novel photoplethysmography (PPG)-based and wrist-oscillometric blood pressure measurement methods against established clinical reference methods (upper-arm cuff measurements on the general ward and invasive arterial blood pressure monitoring (A-line) in the intensive care unit). The main questions the study aims to answer are: * Can novel blood pressure monitoring methods suitable for integration into wearable devices achieve clinically acceptable agreement with established reference measurements? * How does the performance of calibration-dependent wearable devices change over time following calibration? * How does the performance of the investigated methods compare with each other? * How do the investigated methods perform for patients with different pre-existing conditions ? To answer these questions, participants will undergo: * blood pressure measurements using different wearable devices based on PPG and wrist oscillometry * standardized reference blood pressure measurements using an upper-arm cuff (general ward) or an existing invasive arterial line (intensive care unit) * repeated measurements over three consecutive days on the general ward to assess calibration stability and measurement reproducibility,
Who can take part
Inclusion criteria
- Blood pressure measurements can be performed on at least one arm, for example no amputation, dialysis shunt, or obstructive dressing
- Ability to understand the study information and provide written informed consent
- For participants in the intensive care unit: an arterial line placed for clinical reasons
Exclusion criteria
- Wrist circumference exceeds the size range of the investigated wearable devices
- Physical or medical conditions preventing placement of the wearable devices, including relevant skin lesions, wounds, severe edema, or patient restraint
- Inability to provide written informed consent
Where it is running
2 locations listed.
- Careggi University Hospital - Florence, FI, Italy
- University Hospital Dresden - Dresden, Saxony, Germany