Heart and Lung Function Monitoring System

NCT ID: NCT02168049

Last Updated: 2024-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2017-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Heart Diseases Lung Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Heart and Lung Function Monitioring

Group Type EXPERIMENTAL

Integrated CardioRespiratory System

Intervention Type DEVICE

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.

Transthoracic Echocardiography (TTE)

Intervention Type DEVICE

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.

Electrocardiography

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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ECG

Eligibility Criteria

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Inclusion Criteria

* Adult's ≥ 18 years old

Exclusion Criteria

* Wounds, surgical incisions at the site of sensor placement
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kimberly Howard-Quijano, M.D., M.S.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

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Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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ICR14-000670

Identifier Type: -

Identifier Source: org_study_id

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