Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Collect raw data from CS BP Pillow System and Arterial line (A-line) in volunteers. The data collected in the study will be used for development of the CS BP algorithm.
This is a prospective data collection single-site study designed to collect blood pressure (BP) waveforms and estimate BP via the CS BP Pillow System, in parallel with arterial line (A-line data). The data collected will be used for algorithm development of the CS BP system.
The study includes a screening phase followed by BP data collection session using the CS Pillow System and an A-line. Participants will be recruited by the Investigator according to the study eligibility criteria.
A total of 40 participants who meet eligibility criteria will be enrolled in the study in 2 cohorts: Cohort I and Cohort II. Each Cohort will include 20 participants. The cohorts will be identical with respect to study procedures and distribution of sex, body mass index (BMI), age, and blood pressure classification groups.
After informed consent is obtained, demographic information, medical history, current medications use and wrist circumference measurement will be recorded. A modified Allen's test, a lateral difference test and additional assessments will be performed to confirm eligibility criteria. In participants who meet the eligibility criteria, the CS BP Pillow will be placed over the radial artery and an A-line will be inserted into the radial artery of the contralateral hand. A dynamic response calculation will be performed to confirm the integrity of the inserted line.
After the participant has rested for at least 5 minutes, simultaneous BP recordings using the CS BP Pillow System and the A-line will begin and continue for about 1 hour.
Upon completion of data collection, all devices will be removed, and adverse events will be assessed and documented.
The end of study for each participant is defined as the completion of device removal and completion of adverse event follow-up. The end of the study is defined as completion of 40 evaluable participant datasets
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CS BP Pillow System | Experimental | Data collected from the CS BP Pillow System will be compared to data collected from Arterial Line |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CS BP Pillow System | Device | Device: CS Pillow System - The 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 Pillow System will be compared to data collected using Arterial Line. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects with complete protocol-defined multi-modal physiological signal acquisition | The primary outcome measure is the number of subjects with complete protocol-defined multi-modal physiological signal acquisition Multi-modal physiological signal acquisition includes simultaneous recording of: (i) photoplethysmography (PPG); ii) single lead electrocardiography (ECG); iii) tonometry signals from the investigational BP Pillow System ; (iv) continuous invasive arterial blood pressure signals. | day 1, 1 hour |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Element Boulder Avista Adventist Hospital Plaza | Louisville | Colorado | 80027 | United States |
Not provided
| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|