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Heart and Lung Function Monitoring System

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ClinicalTrials.gov Identifier: NCT02168049
Recruitment Status : Unknown
Verified June 2018 by Kimberly Howard-quijano, University of California, Los Angeles.
Recruitment status was:  Recruiting
First Posted : June 20, 2014
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Kimberly Howard-quijano, University of California, Los Angeles

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

Condition or disease Intervention/treatment Phase
Heart Diseases Lung Diseases Device: Integrated CardioRespiratory System Device: Transthoracic Echocardiography (TTE) Device: Electrocardiography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Heart and Lung Function Monitoring System Evaluation
Study Start Date : November 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

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 Name: ECG




Primary Outcome Measures :
  1. Acoustic heart sound electronic data [ Time Frame: 60 minutes during system trial ]
    Heart and lung function monitoring


Secondary Outcome Measures :
  1. Standard echocardiography parameters [ Time Frame: 60 minutes during examination simultaneous with system trial ]
    Transthoracic Echocardiography (TTE)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult's ≥ 18 years old

Exclusion Criteria:

  • Wounds, surgical incisions at the site of sensor placement

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168049


Contacts
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Contact: Jennifer Scovotti, M.A. 1.310.206.4484 jscovotti@mednet.ucla.edu

Locations
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United States, California
Ronald Reagan UCLA Medical Center Recruiting
Los Angeles, California, United States, 90095
Sub-Investigator: Aman Mahajan, M.D., Ph.D.         
Sub-Investigator: William Kaiser, Ph.D.         
Principal Investigator: Kimberly Howard-Quijano, M.D.         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Kimberly Howard-Quijano, M.D., M.S. University of California, Los Angeles
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Responsible Party: Kimberly Howard-quijano, Assistant Clinical Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02168049    
Other Study ID Numbers: ICR14-000670
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Kimberly Howard-quijano, University of California, Los Angeles:
cardiac, respiratory, monitoring
Additional relevant MeSH terms:
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Lung Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases