A Data Collection Study to Collect Blood Pressure (BP) Data Using the CardiacSense BP Watch and CardiacSense Pillow Systems for Algorithm Development
CardiacSense Ltd.
Summary
Collect raw data from CS Watch System, CS BP Pillow System, Arterial line (A-line) and auscultatory cuff measurements in volunteers. The data collected in the study will be used for development of the CS BP algorithms.
Description
This is a prospective single-site data collection study designed to collect blood pressure (BP) waveforms and estimate BP via the CardiacSense (CS) BP Watch and CS BP Pillow Systems, in parallel with arterial line (A-line data), auscultatory BP cuff measurements and SpO2 measurements. The data collected will be used for algorithms development of the CS BP Systems. The study includes a screening phase followed by BP data collection session. Participants will be recruited by the Investigator according to the study eligibility criteria. Each enrolled participant will be fitted with 2 CS BP Watch…
Eligibility
- Age range
- 50–80 years
- Sex
- All
- Healthy volunteers
- Yes
Main Inclusion Criteria: 1. 50-80 years old. 2. Ability and willingness to sign and understand an informed consent form. 3. The participant has a palpable radial pulse in both wrists. 4. The participant is willing and able to be fitted with the investigational devices, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational devices and A-line. 5. Participant has good signal quality with the CS Pillow at both wrists. 6. Participant has good PPG signals in both thumbs. 7. Participant has good ECG signals using t…
Interventions
- DeviceCS BP Watch and CS BP Pillow Systems
The CS BP Watch System is a wrist-worn data acquisition system designed to estimate BP from time-synchronized ECG and PPG signals. The CS Pillow System estimates BP using a combination of ECG and tonometry signals. The system is comprised of a tonometry-based sensor which is embedded in a biocompatible "pillow" for improved sensitivity and comfort. The Pillow is placed over the pulsatile area of the radial artery using a wristband. Data collected using the CS Watch and CS Pillow Systems will be compared to data collected using Arterial Line and auscultatory BP cuff measurements
Location
- Element Boulder Avista Adventist Hospital PlazaLouisville, Colorado