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

Pre Eclampsia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02267577
• Other study ID #: 14-082F-A
• Secondary ID: 51262
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: October 12, 2017

Study information

• Verified date: March 2020
• Source: William Marsh Rice University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 12, 2017
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Willing and able to provide informed consent

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Eclampsia
• Pre Eclampsia
• Pre-Eclampsia

Intervention

Device:
• Sphygmo: Automatic Blood Pressure Monitor
A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals.
• GE Dinamap ProCare Automatic Blood Pressure Monitor
This commercially available gold standard blood pressure monitor will be used as a control to assess the accuracy of the Sphygmo device.

Locations

Country	Name	City	State
United States	Rice University	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
William Marsh Rice University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.	Mean difference of systolic and diastolic blood pressure readings between Sphygmo device and 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.
Primary	Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer.	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.	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.