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
|Condition or disease|
|Blood Pressure Hypertension|
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.
|Study Type :||Observational|
|Actual Enrollment :||100 participants|
|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|
- 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
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
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02111|
|Principal Investigator:||Mohan Thanikachalam||Tufts University|