Wrist Worn Blood Pressure Measurement

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03919136
• Other study ID #: IRB18-1281
• Status: Recruiting
• Start date: August 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: April 2019
• Source: LiveMetric S.A.
• Contact: Gabriel Sayer, MD
• Phone: 773-702-9396
• Email: gsayer[@]medicine.bsd.uchicago.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• Wrist-worn measurement device (LiveMetric)
Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	NYU School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
LiveMetric S.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-Oscillometric Blood Pressure Wrist Worn Data Acquisition and Analysis	Measurements including systolic and diastolic pressures will be assessed and analyzed retrospectively according to the requirements of the standard (ISO 81060-2).	2 years