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

William Marsh Rice University

Status: Completed

Conditions: Pre Eclampsia

Treatments: Device: GE Dinamap ProCare Automatic Blood Pressure Monitor; Device: Sphygmo: Automatic Blood Pressure Monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02267577

14-082F-A

51262 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 90 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Willing and able to provide informed consent

Exclusion criteria

• Unable to provide informed consent

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

Healthy Adults Volunteers

Experimental group

Description:

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.

Treatment:

Device: Sphygmo: Automatic Blood Pressure Monitor

Device: GE Dinamap ProCare Automatic Blood Pressure Monitor