NCT02823873

Validation of Pulsewave Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women

Validation of Pulsewave Oscillometric Wrist Cuff Blood Pressure Monitor in Hypertensive and Normotensive Pregnant and Postpartum Women

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test the accuracy of the Pulsewave wrist blood pressure cuff in pregnant and postpartum women who have either normal blood pressure or high blood pressure.

Detailed description

The study will include a series of nine blood pressure measurements. The measurements will alternate between a gold standard auscultatory blood pressure measurement and the Pulsewave monitor. A trained clinician will be used for gold standard measurements using an appropriately sized cuff around the upper arm, a sphygmomanometer, and a stethoscope. Systolic blood pressure is defined by the first Korotkoff sound; diastolic blood pressure is defined by the fifth Korotkoff sound. Measurements by the Pulsewave monitor will be performed using a proprietary oscillometric wrist cuff automated by a computer tablet and software made by CloudDx Inc. Women will be seated for 5 to 10 minutes before the first blood pressure measurement. During this time, 4 circumference measurements will be taken of the arm and wrist. 1. The armpit will be measured as proximally as possible. 2. The mid upper arm will be recorded by measuring at the halfway point between the acromion and the olecranon process. 3. The distal upper arm measurement will be taken approximately 2 cm proximal to the antecubital crease. 4. The wrist will be measured approximately 2 cm proximal to the wrist flexion crease. The first two blood pressure measurements will be used as a way to orient the subject to each device and the methods so that they are comfortable with the cuff and the process. The seven subsequent measurements will be used for analysis. There will be a 30 second to 60 second period between blood pressure measurements.

Conditions

• Hypertension

Interventions

Type	Name	Description
DEVICE	Pulsewave oscillometric wrist cuff blood pressure monitor	Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-07-01
• First posted: 2016-07-06
• Last updated: 2016-07-22

Locations

1 site across 1 country: United States