NCT02267577

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: William Marsh Rice University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Pre Eclampsia

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2015-10-01
• Completion: 2017-10-12
• First posted: 2014-10-17
• Last updated: 2020-03-06
• Results posted: 2019-02-15

Locations

1 site across 1 country: United States