Data Collection Study Using CS BP Pillow System
A Data Collection Study to Collect Blood Pressure Data Using the CardiacSense BP Pillow System for Algorithm Development
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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, CS BP Plate System and IR-Pillow in parallel with arterial line (A-line data). 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 using the CS Pillow System, CS BP Plate System, IR-Pillows and an A-line. Participants will be recruited by the Investigator according to the study eligibility criteria.
A total of 50 participants who meet eligibility criteria will be enrolled in the study in 3 cohorts: Cohort I and Cohort II will include 20 participants, and Cohort III will include 10 participants.
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 study systems will be fitted and an A-line will be inserted into the radial artery. 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, CS BP Plate System, IR Pillows and 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 50 evaluable participant datasets
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Colorado
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Louisville, Colorado, United States, 80027
- Element Boulder Avista Adventist Hospital Plaza
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 20-80 years old.
- Ability and willingness to sign and understand an informed consent form.
- The participant has a palpable radial pulse in both wrists.
- The participant is willing and able to be fitted with the investigational device, A-line, and reference cuff, and is willing and able to undergo all study procedures, including 1 hour of recording with the investigational device and A-line.
- The participant was fitted with both CS BP Plate System devices (one for each hand) and CardiacSense technician has determined the measurement quality to be sufficient.
Exclusion Criteria:
- Participant who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the participant or interfere with the data collected.
- Participant whose body habitus precludes them from wearing the investigational device on their wrists.
- Female participants who self-reported as pregnant based on a urine pregnancy test, or who are self-reported as trying to get pregnant or who are breastfeeding.
- Participant whose BMI is greater than 35.
- Participant with a documented medical history of cardiac arrhythmia.
- Participant with diagnosed diabetes mellitus.
- Participant with implanted cardiac defibrillators or pacemakers, Ventricular Assist Device (VAD) or other mechanical circulatory support devices, whether intracorporal or extracorporeal.
- Participant with stage 4 or stage 5 end-stage renal disease, or participants with arteriovenous shunts.
- Participant with pheochromocytoma or primary hyperaldosteronism.
- Participant with diagnosed heart failure with New York Heart Association (NYHA) class III/IV, or participants with a history of stroke.
- Participant with a known clotting disorders or currently taking a prescription anticoagulants (daily aspirin use is permitted).
- Participant with an infection requiring antibiotics.
- Participant with peripheral artery disease
- Participants with compromised circulation, including Raynaud's syndrome.
- Participant has a fracture, severe trauma, or anatomical deformity involving the wrist intended for placement of the investigational devices, which could interfere with proper fitting or function of the devices.
- Participant with moderate to severe valvulopathies.
- Participant with primary vasculitis.
- Participant with tremors or otherwise unable to remain still for 1 hour.
- The left to right arm lateral difference of the average systolic blood pressure values is more than 15 mmHg or the lateral difference of the average diastolic blood pressure values is more than 10 mmHg.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: CS BP Pillow System, CS BP Plate System and IR Pillows
Data collected from the systems will be compared to data collected from Arterial Line
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Device: CS Pillow System CS Pillow System estimates blood pressure using ECG and tonometry signals. It includes a tonometry sensor embedded in a biocompatible pillow, positioned over the radial artery with a wristband for improved sensitivity and comfort and ECG chest wet electrodes fitted on the torso. CS BP Plate System estimates blood pressure using ECG and PPG. The system consists of a handheld, battery-operated Plate with integrated optical and ECG sensors contacted by the thumb. Infrared (IR) Pillow contain a PPG sensor (IR LED and photodiode) embedded in a biocompatible "pillow. The IR Pillow is placed over the radial artery. This sensor enables estimation of arterial compliance, an important factor influencing the blood pressure-blood volume relationship. Data collected using the CS BP Pillow System and the CS Plate System will be compared to data collected using Arterial Line.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of subjects with complete protocol-defined multi-modal physiological signal acquisition
Time Frame: day 1, 1 hour
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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) IR PPG signals (v) continuous invasive arterial blood pressure signals. |
day 1, 1 hour
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 027_BP_DC_US
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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