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Completed

NCT Number: NCT03128944

Feasibility Assessment of the Blood Pressure Imager, a Continuous Blood Pressure Monitor

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tufts University

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Comparison of BPI measurements with reference blood pressure measurements

    Time frame: 1 hour

    Comparison of BPI measurements with reference blood pressure measurements with commercially available cuff-based blood pressure measuring device

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Registry information

Official study title

Development of the Blood Pressure Imager

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2017
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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