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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2017-10-12

Brief Summary

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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.

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Detailed Description

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Conditions

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Pre Eclampsia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Participants enrolled in the study will have their blood pressure measured multiple times with both the GE Dinamap Procare commercial blood pressure monitor and Sphygmo, the experimental blood pressure monitoring device.

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Healthy Adults Volunteers

Men and women over the age of 18 will have their blood pressure measured with both the Sphygmo: Automatic Blood Pressure Monitor device and the GE Dinamap ProCare automatic blood pressure monitor.

Group Type EXPERIMENTAL

Sphygmo: Automatic Blood Pressure Monitor

Intervention Type DEVICE

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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type DEVICE