Heart and Lung Function Monitoring System

NCT02168049 | Completed DMC

• 1 other identifier: ICR14-000670
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Diseases; Lung Diseases

Keywords

cardiac, respiratory, monitoring

Outcome Measures

Primary Outcomes (1)

• Acoustic heart sound electronic data

  Heart and lung function monitoring

  60 minutes during system trial

Secondary Outcomes (1)

• Standard echocardiography parameters

  60 minutes during examination simultaneous with system trial

Study Arms (1)

Heart and Lung Function Monitioring

EXPERIMENTAL

Device: Integrated CardioRespiratory System; Device: Transthoracic Echocardiography (TTE); Device: Electrocardiography

Interventions

Integrated CardioRespiratory System 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.

Heart and Lung Function Monitioring

Transthoracic Echocardiography (TTE) 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.

Heart and Lung Function Monitioring

Electrocardiography 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.

Also known as: ECG

Heart and Lung Function Monitioring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult's ≥ 18 years old

You may not qualify if:

• Wounds, surgical incisions at the site of sensor placement

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

Ronald Reagan UCLA Medical Center

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Heart Diseases; Lung Diseases

Interventions

Echocardiography; Electrocardiography

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Electrodiagnosis

Study Officials

• Kimberly Howard-Quijano, M.D., M.S.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 20, 2014
• Study Start: November 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)