Back to resultsHeart and Lung Function Monitoring System
Primary Purpose
Heart Diseases, Lung Diseases
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated CardioRespiratory System
Transthoracic Echocardiography (TTE)
Electrocardiography
Sponsored by
About this trial
This is an interventional other trial for Heart Diseases focused on measuring cardiac, respiratory, monitoring
Eligibility Criteria
Inclusion Criteria:
- Adult's ≥ 18 years old
Exclusion Criteria:
- Wounds, surgical incisions at the site of sensor placement
Sites / Locations
- Ronald Reagan UCLA Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Heart and Lung Function Monitioring
Arm Description
Outcomes
Primary Outcome Measures
Acoustic heart sound electronic data
Heart and lung function monitoring
Secondary Outcome Measures
Standard echocardiography parameters
Transthoracic Echocardiography (TTE)
Full Information
NCT ID
NCT02168049
First Posted
June 11, 2014
Last Updated
June 8, 2018
Sponsor
University of California, Los Angeles
1. Study Identification
Unique Protocol Identification Number
NCT02168049
Brief Title
Heart and Lung Function Monitoring System
Official Title
Heart and Lung Function Monitoring System Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Lung Diseases
Keywords
cardiac, respiratory, monitoring
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Heart and Lung Function Monitioring
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Integrated CardioRespiratory System
Intervention Description
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
Intervention Name(s)
Transthoracic Echocardiography (TTE)
Intervention Description
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
Intervention Name(s)
Electrocardiography
Other Intervention Name(s)
ECG
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acoustic heart sound electronic data
Description
Heart and lung function monitoring
Time Frame
60 minutes during system trial
Secondary Outcome Measure Information:
Title
Standard echocardiography parameters
Description
Transthoracic Echocardiography (TTE)
Time Frame
60 minutes during examination simultaneous with system trial
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult's ≥ 18 years old
Exclusion Criteria:
Wounds, surgical incisions at the site of sensor placement
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Scovotti, M.A.
Phone
1.310.206.4484
Email
jscovotti@mednet.ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kimberly Howard-Quijano, M.D., M.S.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ronald Reagan UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aman Mahajan, M.D., Ph.D.
First Name & Middle Initial & Last Name & Degree
William Kaiser, Ph.D.
First Name & Middle Initial & Last Name & Degree
Kimberly Howard-Quijano, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Heart and Lung Function Monitoring System
We'll reach out to this number within 24 hrs