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

NCT02267577 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2020-03-06

Study results available
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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

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.

Sponsors & Collaborators

  • William Marsh Rice University

    lead OTHER

Principal Investigators

  • Rebecca R Kortum, PhD · William Marsh Rice University

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-10-31
Completion
2017-10-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02267577 on ClinicalTrials.gov