Advanced Wireless, Wearable Sensors for Continuous Hemodynamic Monitoring

September 27, 2022 updated by: Shuai (Steve) Xu, Northwestern University
Percent agreement of vital signs monitoring between the experimental sensor and standard of care monitoring

Study Overview

Status

Completed

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

42

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

    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

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 to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Cardiology patients

Description

Inclusion Criteria

  1. Patient's aged 18-65
  2. Patient's scheduled to undergo a Trans-thoracic Echocardiogram (TTE) in an outpatient cardiology clinic or admitted to the Cardiac Care Unit with a swan ganz catheter in place for continuous invasive hemodynamic monitoring

Exclusion Criteria

  1. Patient's with fragile skin or skin conditions that would prevent them from having a sensor placed
  2. Patients undergoing exercise or drug induced cardiac stress test
  3. Patients with a visible wound at site of sensor placement 3.4. Patients with structural or functional limitations to peripheral blood flow (known upper extremity peripheral arterial disease, use of vasopressors etc.).

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
Adults
Adults scheduled to receive a TTE (Trans-esophogeal echocardiogram)
vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent agreement with pilot sensor and current standard of vital signs monitoring
Time Frame: 2 years
Percent agreement with pilot sensor and current standard of vital signs monitoring
2 years

Collaborators and Investigators

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

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)

June 1, 2020

Primary Completion (Actual)

November 23, 2020

Study Completion (Actual)

September 5, 2022

Study Registration Dates

First Submitted

April 15, 2020

First Submitted That Met QC Criteria

April 22, 2020

First Posted (Actual)

April 27, 2020

Study Record Updates

Last Update Posted (Actual)

September 28, 2022

Last Update Submitted That Met QC Criteria

September 27, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00210413

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.

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