The Purpose of This Clinical Trial is to Evaluate the Accuracy of Blood Pressure Measurement of HiCardi M350 Compared to Blood Pressure Measured by Auscultatory Sphygmomanometer in Adult Volunteers (Including Those Meeting Blood Pressure Distribution Requirements) in Accordance With ISO 81060-2:2018

Condition(s) studied

Investigational drug(s) / intervention(s)

HiCardi M350: HiCardi M350 is a wearable patient monitoring device used to measure systolic and diastolic blood pressure. In this study, the device will be attached to each participant and calibrated according to the predefined procedure. Blood pressure values measured by HiCardi M350 will be compared with reference values obtained using an auscultatory sphygmomanometer and mechanical stethoscope by two independent observers.

Study summary

This prospective, single-center, single-arm pivotal clinical trial is designed to evaluate the accuracy of blood pressure measurements obtained using the HiCardi M350 patient monitor compared with measurements obtained using an auscultatory sphygmomanometer.

The study will enroll adult volunteers aged 19 years or older, including participants needed to satisfy the blood pressure distribution requirements of ISO 81060-2:2018. The planned enrollment is 100 participants, considering the ISO 81060-2:2018 minimum requirement of 85 participants and an estimated dropout rate of approximately 15%. The study is also designed to obtain at least 255 valid paired blood pressure values.

After written informed consent, participants will undergo screening assessments, including demographics, vital signs, medical and surgical history, prior and concomitant medications, pregnancy testing for women of childbearing potential, bilateral arm circumference measurement, eligibility assessment, and adverse event assessment. On the blood pressure test day, eligibility will be reconfirmed, an enrollment number will be assigned, HiCardi M350 calibration will be performed, and blood pressure measurements will be obtained using both HiCardi M350 and the reference auscultatory method.

The primary effectiveness endpoint is the difference between systolic and diastolic blood pressure values measured by HiCardi M350 and the reference sphygmomanometer under resting conditions. Accuracy will be evaluated according to ISO 81060-2:2018 using Criteria 1 and Criteria 2. Safety will be evaluated based on adverse events, adverse device effects, serious adverse events, serious adverse device effects, unanticipated adverse device effects, and device deficiencies.

Eligibility

Primary outcome measure(s)

• Difference between systolic and diastolic blood pressure measurements obtained using HiCardi M350 and a reference auscultatory sphygmomanometer — After completion of all participants' data collection (within approximately 7 months of enrollment period)
  The primary outcome is the difference between systolic and diastolic blood pressure values measured by HiCardi M350 and the reference auscultatory sphygmomanometer under resting conditions. Accuracy will be assessed separately for systolic and diastolic blood pressure according to ISO 81060-2:2018 Criteria 1 and Criteria 2.

Trial sites (1)

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