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NCT02168049 Clinical Trial

Heart and Lung Function Monitoring System

Heart Diseases Clinical Trial

Official title:
Heart and Lung Function Monitoring System Evaluation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02168049
Other study ID # ICR14-000670
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 2014
Est. completion date September 2017

Study information
Verified date March 2024
Source University of California, Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult's = 18 years old Exclusion Criteria: - Wounds, surgical incisions at the site of sensor placement

Study Design

Related Conditions & MeSH terms

Intervention

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.
• 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.
• 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.

Locations
Country Name City State
United States Ronald Reagan UCLA Medical Center Los Angeles California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acoustic heart sound electronic data Heart and lung function monitoring 60 minutes during system trial
Secondary Standard echocardiography parameters Transthoracic Echocardiography (TTE) 60 minutes during examination simultaneous with system trial
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