Blood Pressure Monitoring, Cuff, Hypertension, Photoplethysmography, Wearable Devices
Conditions
Brief summary
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,
Interventions
None listed
Sponsors
Technische Universität Dresden
Careggi Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of wearable blood pressure measurement methods with clinical reference measurements | General ward: At each measurement session on study days 1, 2, and 3. ICU: At measurement session on study day 1, approx. 2 hours after device calibration | The mean difference and standard deviation of the differences in systolic and diastolic blood pressure, expressed in mmHg, between each investigated wearable blood pressure measurement method and the corresponding reference method. |
Countries
Germany, Italy
Contacts
CONTACTMoritz Herzog, MD
Outcome results
None listed