Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor

Not Applicable

Not yet recruiting

• Conditions: Hypotension; Hypertension; Blood Pressure; Blood Pressure, Low; Blood Pressure, High
• Interventions: Device: CART BP; Device: sphygmomanometer

• Registration Number: NCT06513975
• Lead Sponsor: Sky Labs

Brief 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.

Detailed Description

There is a non-invasive technique called Photoplethysmography (PPG) that overcomes the limitations of traditional auscultatory and oscillometric methods. Photoplethysmography uses light-emitting diodes (LEDs) to illuminate human tissue, specifically targeting blood vessels, and employs sensors to measure the volume of blood flowing through the tissue. This technique can be applied to various parts of the small arterial system in the human body, enabling cuffless blood pressure measurement. As a result, it simplifies blood pressure monitoring for subjects and allows for extended observation periods.

With the advancement of cuffless blood pressure monitors, the European Society of Hypertension (ESH) has established recommendations to ensure accurate measurements. The recommendations consider variations in measurement height and compare accuracy after blood pressure is elevated through aerobic exercise or low-intensity repetitive exercises, such as handgrip exercises. This study aims to follow the 2023 European Society of Hypertension recommendations by measuring blood pressure with the arm positioned vertically more than 20 centimeters below the standard position and comparing the results obtained after repeated handgrip exercises with those obtained using the standard method.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-16
• Study First Submitted QC: 2024-07-16
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-23
• Last Update Posted: 2024-07-24
• Study Start: 2024-08-15
• Primary Completion: 2024-12-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects requiring 24-hour ambulatory blood pressure monitoring	sphygmomanometer	Subjects prescribed for ambulatory blood pressure monitor (ABPM) measure 24-hour blood pressure using both the CART BP and sphygmomanometer
Subjects requiring 24-hour ambulatory blood pressure monitoring	CART BP	Subjects prescribed for ambulatory blood pressure monitor (ABPM) measure 24-hour blood pressure using both the CART BP and sphygmomanometer

Primary Outcome Measures

Name	Time	Method
Mean error and standard deviations of differences between CART BP and Reference	1 hour	The primary outcome measure is the mean error and standard deviation (SD) of the differences between the CART BP device and the reference device. This endpoint is determined based on the European Hypertension Society (ESH) recommendation, which states that the pass criteria are as per International Organization for Standardization (ISO) 81060-2:2018: a mean error within 5 mmHg and an standard deviation within ±8 mmHg.