Wrist Worn Blood Pressure Measurement

April 17, 2019 updated by: LiveMetric S.A.

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern Memorial Hospital
      • Chicago, Illinois, United States, 606037
        • Recruiting
        • University of Chicago
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sara Kalantari, MD
        • Sub-Investigator:
          • Gene Kim, MD
        • Sub-Investigator:
          • Bryan Smith, MD
        • Sub-Investigator:
          • Nitasha Sarswat, MD
    • New York
      • New York, New York, United States, 10016
        • Recruiting
        • NYU School of Medicine
        • Contact:
          • Greta Piper, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with an arterial line used for continuous blood pressure monitoring.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Objective
Evaluation of the devices accuracy referenced to interventional (A-line) measurement.
Device: Wrist-worn measurement device (LiveMetric)
Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LiveMetric S.A.

Investigators

  • Principal Investigator: Gabriel Sayer, MD, University of Chicago

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2018

Primary Completion (ANTICIPATED)

October 1, 2019

Study Completion (ANTICIPATED)

October 1, 2019

Study Registration Dates

First Submitted

April 15, 2019

First Submitted That Met QC Criteria

April 15, 2019

First Posted (ACTUAL)

April 18, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB18-1281

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Heart Failure

Clinical Trials on Wrist-worn measurement device (LiveMetric)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Australia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe