Wearable Blood-Pressure Monitoring Comparison Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age21-85
SponsorTechnische Universität Dresden

About this trial

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,

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Hospitalized adult patients aged 21 to 85 years who are treated on participating general wards or intensive care units at the hospital and are able to provide written informed consent.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

120 Participants
are grouped into 2 trial groups
Group A: Cohort at general ward
Group B: Cohort at ICU

Trial outcomes

Primary outcomes

1

Agreement of wearable blood pressure measurement methods with clinical reference measurements

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.

Time frame
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

Secondary outcomes

Other outcomes

Sponsors and contacts

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