NCT03919136

Wrist Worn Blood Pressure Measurement

Accuracy of Non-Invasive Non-Oscillometric Blood Pressure Wrist Worn Measurement

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: LiveMetric S.A. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study, the investigators are testing the accuracy of a wrist-worn measurement device by comparing its blood pressure measurement to arterial line (A-line) blood pressure monitors. The device is similar in style and fit to popular activity bands, but it is unique in that it measures blood pressure.

Detailed description

LiveMetric has developed a wrist-worn measurement device intended for use as a standalone device, designed for measurement of intermittent blood pressure for individuals suffering from hypertension or other conditions where monitoring of blood pressure is of importance. The wrist-worn measurement device is intended to be worn on the wrist for intermittent measurements of Blood pressure. The use does not require any special action from the user apart from wearing the band on either their left or right wrist. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet all the time or most of the time. The study will include subjects that are hospitalized in the ICU and/or any of the cardiology departments or affiliating units such as Cath lab, heart transplant unit, etc..) and are continually monitored by an intra-arterial blood pressure line (A-line). A medical professional will measure simultaneous non-invasive auscultatory readings to determine the lateral difference for later adjustment of calculation. A medical professional or a company representative accompanied by a medical professional will place the device on the opposite limb than the one having the A-line, providing the location of the placement has intact skin. During the measurement stage, BP values are simultaneously recorded from the reference invasive A-line and the wrist worn device.

Conditions

• Blood Pressure
• Heart Failure
• Advanced Heart Failure
• Heart Failure，Congestive

Interventions

Type	Name	Description
DEVICE	Wrist-worn measurement device (LiveMetric)	Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.

Timeline

• Start date: 2018-08-01
• Primary completion: 2019-10-01
• Completion: 2019-10-01
• First posted: 2019-04-18
• Last updated: 2019-04-19

Locations

3 sites across 1 country: United States