Heart and Lung Function Monitoring System

March 4, 2024 updated by: University of California, Los Angeles

Heart and Lung Function Monitoring System Evaluation

The investigator goal is to test a new device to see if it can provide continuous and simultaneous monitoring of heart and lung function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate and guide progress in the development of a new instrument that may provide continuous, integrated monitoring of heart and lung function.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

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
    • California
      • Los Angeles, California, United States, 90095
        • Ronald Reagan UCLA Medical Center

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

Yes

Description

Inclusion Criteria:

  • Adult's ≥ 18 years old

Exclusion Criteria:

  • Wounds, surgical incisions at the site of sensor placement

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

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Heart and Lung Function Monitioring
Device: Integrated CardioRespiratory System
Participants will be asked to wear a non-invasive band on their upper abdomen while laying down. This band includes acoustic sensors. A remote monitoring device will continuously monitor and record heart rate and lung volumes and function.
Device: Transthoracic Echocardiography (TTE)
Participants will undergo a TTE examination. During the TTE, a technician obtains views of the heart by moving a small instrument called a transducer to different locations on the chest or abdominal wall.
Device: Electrocardiography
Participants will also have ECG monitoring as part of the TTE exam, which records the electrical activity of the heart using electrodes placed on the body.
Other Names:
  • ECG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acoustic heart sound electronic data
Time Frame: 60 minutes during system trial
Heart and lung function monitoring
60 minutes during system trial

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard echocardiography parameters
Time Frame: 60 minutes during examination simultaneous with system trial
Transthoracic Echocardiography (TTE)
60 minutes during examination simultaneous with system trial

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: Kimberly Howard-Quijano, M.D., M.S., University of California, Los Angeles

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)

November 1, 2014

Primary Completion (Actual)

September 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

June 11, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimated)

June 20, 2014

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICR14-000670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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