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

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ClinicalTrials.gov Identifier: NCT03128944
Recruitment Status : Completed
First Posted : April 25, 2017
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mohan Thanikachalam, Tufts University

Brief Summary:
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.

Condition or disease
Blood Pressure Hypertension

Detailed Description:

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.

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Development of the Blood Pressure Imager
Actual Study Start Date : May 1, 2017
Actual Primary Completion Date : October 30, 2019
Actual Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study accepts adult (age of 18 years and above) volunteers with or without high blood pressure who are physically and mentally able to consent.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128944


Locations
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United States, Massachusetts
Tufts University
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts University
Investigators
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Principal Investigator: Mohan Thanikachalam Tufts University
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Responsible Party: Mohan Thanikachalam, Research Assistant Professor, Tufts University
ClinicalTrials.gov Identifier: NCT03128944    
Other Study ID Numbers: 12351
First Posted: April 25, 2017    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases