Feasibility Assessment of the Blood Pressure Imager, a Continuous Blood Pressure Monitor
| Status: | Recruiting |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/15/2019 |
| Start Date: | May 1, 2017 |
| End Date: | November 30, 2019 |
| Contact: | Mohan Thanikachalam, MD |
| Email: | mohan.thanikachalam@tufts.edu |
| Phone: | 6177759402 |
Development of the Blood Pressure Imager
The investigators are developing Blood Pressure Imager (BPI), which is a new technology that
does not require cuffs or expensive equipment, and can be used by untrained individuals in
underserved, low-resource environments at their own homes or regional care settings. Over the
last one-year the investigators have developed the BPI prototype, which is ready for testing.
BPI is a wrist device that includes a camera, color lights and soft membrane with a
reflective coating. In this device feasibility study, the BPI will be placed over the radial
artery at the wrist with the help of a wrist strap. The primary purpose of this feasibility
study is to compare the BPI with a commercially available cuff-based blood pressure measuring
devices.
does not require cuffs or expensive equipment, and can be used by untrained individuals in
underserved, low-resource environments at their own homes or regional care settings. Over the
last one-year the investigators have developed the BPI prototype, which is ready for testing.
BPI is a wrist device that includes a camera, color lights and soft membrane with a
reflective coating. In this device feasibility study, the BPI will be placed over the radial
artery at the wrist with the help of a wrist strap. The primary purpose of this feasibility
study is to compare the BPI with a commercially available cuff-based blood pressure measuring
devices.
If the participant volunteers to participate in this study, after signing the informed
consent, responses to background data - age, gender, height, weight, wrist circumference of
dominant arm, history of high blood pressure, diabetes, high cholesterol and cardiovascular
disease - will be collected; The BPI will be strapped to the right or left wrist making sure
it is comfortable to the participant and the readings from the BPI will be recorded in a
computer. The continuous BPI readings will be recorded for 2 minutes. Simultaneously, blood
pressure readings will be obtained from a cuff-based, commercially available blood pressure
measuring device placed in the same arm. The research team will take a minimum 3 and maximum
6 sets of readings. At the end of the BPI readings, we will place an ultrasound probe of the
wrist at the level of the wrist to assess the size of the radial artery and depth of the
artery from the skin.
Participant Timeline: The collection of the background data will take 5 to 10 mins. The
placement of the BPI and cuff-blood pressure device and the data collection will take about
15 to 20 mins. The ultrasound image collection will 10 to 15 mins. Overall, the study
procedures will be less than an hour.
consent, responses to background data - age, gender, height, weight, wrist circumference of
dominant arm, history of high blood pressure, diabetes, high cholesterol and cardiovascular
disease - will be collected; The BPI will be strapped to the right or left wrist making sure
it is comfortable to the participant and the readings from the BPI will be recorded in a
computer. The continuous BPI readings will be recorded for 2 minutes. Simultaneously, blood
pressure readings will be obtained from a cuff-based, commercially available blood pressure
measuring device placed in the same arm. The research team will take a minimum 3 and maximum
6 sets of readings. At the end of the BPI readings, we will place an ultrasound probe of the
wrist at the level of the wrist to assess the size of the radial artery and depth of the
artery from the skin.
Participant Timeline: The collection of the background data will take 5 to 10 mins. The
placement of the BPI and cuff-blood pressure device and the data collection will take about
15 to 20 mins. The ultrasound image collection will 10 to 15 mins. Overall, the study
procedures will be less than an hour.
Inclusion Criteria:
- Tests will be performed with any adult volunteer who is physically and mentally able
to perform the experimental tasks.
Exclusion Criteria:
- We will restrict the experiments to adult volunteers who are physically and mentally
able to consent.
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