Wrist Worn Blood Pressure Measurement

LiveMetric S.A.

Status

Unknown

Conditions

Heart Failure

Heart Failure，Congestive

Blood Pressure

Advanced Heart Failure

Treatments

Device: Wrist-worn measurement device (LiveMetric)

Study type

Observational

Funder types

Other

Identifiers

NCT03919136

IRB18-1281

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients who have a pre-existing intra-arterial blood pressure (A-Line) line for standard care
Patients that are ≥18 years of age.

Exclusion criteria

Body habitus that precludes patients from wearing a device on their wrist
Subjects without normal palpable radial artery pulse, whether congenital, due to medical intervention, or otherwise
Subjects with wrist circumference less than 155mm or greater than 210mm
Subjects implanted with pacemaker, VAD's or other mechanical circulatory support device whether intracorporeal or extracorporeal
Patients that do not have an intra-arterial blood pressure line.