Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor
Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor: Evaluation of Blood Pressure Measurement by Height and Physical Activity
Sky Labs
50 participants
Nov 22, 2024
INTERVENTIONAL
Conditions
Summary
This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. The comparison is conducted in accordance with the 2023 European Society of Hypertension (ESH) Recommendations, focusing on patients with suspected hypertension or hypotension. The evaluation includes accuracy measurements across various postures and during different exercise periods.
Eligibility
Inclusion Criteria3
- Subjects aged 18 years or older but younger than 80 years
- Individuals who voluntarily decide to participate in this clinical trial and provide written consent to the information and consent form
- Individuals willing to comply with the clinical trial protocol
Exclusion Criteria9
- Subjects who do not consent to the study
- Obese individuals with a Body Mass Index (BMI) of 30 or higher (concerns about measurement errors as the standard 24-hour ambulatory blood pressure monitor cuff may not fit the arm properly)
- Patients or volunteers who are pregnant
- Patients or volunteers with underlying heart diseases: those with a history of hospitalization for heart failure, valvular disease, or myocardial infarction
- Patients or volunteers diagnosed with atrial fibrillation on a 12-lead electrocardiogram (ECG) within the past 6 months
- Patients or volunteers with end-stage renal disease (undergoing dialysis)
- Patients or volunteers unable to perform repeated exercises required for the study
- Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg)
- Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg) and/or a diastolic blood pressure (DBP) exceeding 100 millimeters of mercury (mmHg) (for exercise tests)
Interventions
A ring-type medical device worn by the subject that non-invasively measures systolic and diastolic blood pressure, as well as pulse rate.
Blood pressure measurement method utilizing a two-headed stethoscope, allowing two observers to simultaneously hear the Korotkoff sounds.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06513975