CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 90 enrolled
Drug / intervention
Sphygmo: Automatic Blood Pressure Monitor +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02267577
NCT02267577N/ACompleted

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

William Marsh Rice University·interventional·Posted Oct 17, 2014·Updated Mar 6, 2020

In Brief

A clinical study evaluating Sphygmo: Automatic Blood Pressure Monitor and GE Dinamap ProCare Automatic Blood Pressure Monitor for Pre Eclampsia. Completed, enrolled 90 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPre Eclampsia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 17, 2014
Enrollment StartJan 1, 2015
Primary CompletionOct 1, 2015
Study CompletionOct 12, 2017
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 11.7 years ago

Interventions

Sphygmo: Automatic Blood Pressure Monitordevice

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 Monitordevice

This commercially available gold standard blood pressure monitor will be used as a control to assess the accuracy of the Sphygmo device.