N/A N=85 Device Feasibility

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

Pre Eclampsia

Bottom Line

View on ClinicalTrials.gov: NCT02267577 ↗

Enrolled (actual)

Serious AEs

1.2%

Results posted

Feb 2019

Primary outcome: Primary: Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard. — 122.5; 74.5; 123.1; 72.1 mmHg

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Sphygmo: Automatic Blood Pressure Monitor (Device); GE Dinamap ProCare Automatic Blood Pressure Monitor (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: William Marsh Rice University
Primary completion: Oct 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Accuracy of Blood Pressure Measurement by Sphygmo Relative to the Clinical Standard.	122.5; 74.5; 123.1; 72.1	—
PRIMARY Percentage of Sphygmo Readings That Were With < 5 mmHg, < 10 mmHg, and < 15 mmHg of the Readings by the Gold Standard Sphygmomanometer.	56; 79; 92; 53; 77; 90	—

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Unable to provide informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02267577). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.