Accuracy Assessment of an Automatic Blood Pressure Measurement Device in Adult Volunteers

Not Applicable

Completed

Conditions: Pre Eclampsia

Registration Number: NCT02267577

Lead Sponsor: William Marsh Rice University

Brief Summary: The research team has developed an automatic blood pressure monitor (Sphygmo) to be used for the monitoring and diagnosis of pre-eclampsia in pregnant women, particularly in low-resource settings where current monitoring is limited.

90 adult volunteers will be enrolled by researchers at Rice University. The participant will be seated in a comfortable chair with arm at heart level. Arm circumference will be measured and a blood pressure cuff will be placed on the arm. The cuff will be inflated and blood pressure measurements will be taken by a commercially available device and by the Sphygmo device. Blood pressure measurements from both devices will be recorded. The participant's blood pressure will be measured up to 9 times with a waiting period of 45-60 seconds between each measurement.

The results of this study will be used to optimize the blood pressure detection algorithm and thus further develop the device.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 90

Inclusion Criteria

18 years of age or older
Willing and able to provide informed consent

Exclusion Criteria

Unable to provide informed consent

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer.	Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.	The British Hypertension society defines a specific criteria for the accuracy of a sphygmomanometer. Devices are graded according to the cumulative percentage of readings that have an absolute difference between the more favorable observer's mercury sphygmomanometer readings and the test device of \< 5 mmHg, \< 10 mmHg, and \< 15 mmHg. A letter grade of "A" requires that over 60%, 85%, and 95% were achieved in the \< 5 mmHg, \< 10 mmHg, and \<15 mmHg categories, respectively. A letter grade of "B" requires that over 50%, 75%, and 90% were achieved in the \< 5 mmHg, \< 10 mmHg, and \<15 mmHg categories, respectively. The test device achieved a grade of (B/B) with the validation data from this study.
Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.	Blood pressure was measured an average of 9 times for each participant during their single visit and the mean of these measurements was recorded and used for analysis. The measurement period lasted approximately 30-45 minutes.	Mean difference of systolic and diastolic blood pressure readings between Sphygmo device and the gold standard sphygmomanometer.

Secondary Outcome Measures