An observational study in Blood Pressure and Hypertension, sponsored by Tufts University. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-27.
Sponsored by Tufts University · Observational
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.
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.
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 100 is below the median of 210 across 1,359 observational studies indexed under Hypertension.
Browse Hypertension studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Study accepts adult (age of 18 years and above) volunteers with or without high blood pressure who are physically and mentally able to consent.
Exclusion Criteria:
Comparison of BPI measurements with reference blood pressure measurements
Comparison of BPI measurements with reference blood pressure measurements with commercially available cuff-based blood pressure measuring device
Time frame: 1 hour
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Tufts University