Blood Pressure Data Collection Using CardiacSense Watch and Pillow Systems to Develop Measurement Algorithms in Adults 50 to 80 Years

What this Trial Is About

Researchers are conducting a prospective study to collect blood pressure waveforms using CardiacSense CS BP Watch and CS BP Pillow Systems alongside arterial line A-line data and auscultatory blood pressure cuff measurements. The collected data aims to support the development of algorithms for the CS BP Systems. The study involves adult volunteers aged 50 to 80 years and includes a screening phase followed by a blood pressure data collection session. Participants who meet eligibility criteria will wear two CS BP Watches one on each hand and a CS BP Pillow. An arterial line will be inserted into the radial artery to provide reference blood pressure data. The study includes simultaneous recordings from these devices and periodic dual-observer auscultatory BP cuff measurements over a one-hour period. After data collection, devices are removed, and any adverse events are recorded. Participants will provide demographic and medical history information during screening, along with physical measurements such as wrist and bicep circumference and baseline vital signs. Eligibility tests include a modified Allens test and signal quality assessments for the devices. The primary outcome is the number of participants completing the full protocol with multi-modal physiological signal acquisition in one hour. The study ends after at least 100 valid datasets are collected, including follow-up for any adverse events after device removal.

Data Collection Study Using CS (CardiacSense) BP (Blood Pressure) Watch and Pillow Systems