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Clinical Trials/NCT03936413
NCT03936413WithdrawnNot Applicable

Artificial Intelligence in Echocardiography: a Pilot Study of Bay Labs Technology in Image Acquisition, Education, and Analysis

New York Presbyterian Hospital0 sitesStarted: January 13, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Primary Endpoint
Echocardiogram image acquisition quality

Study Overview

Brief Summary

The goal of this study is to determine whether the Bay Labs artificial intelligence (AI) system can be used by minimally trained operators to obtain diagnostic quality echocardiographic images.

Detailed Description

Echocardiography is a common and essential tool in the diagnosis of cardiovascular disease. Using ultrasound, this technique allows for non-invasive assessment of cardiac function, including systolic function, diastolic function, heart chamber quantification, and diagnosis and quantification of valvular abnormalities. Usage of echocardiography has increased each year; over 7 million echocardiograms were performed in 2011 in the Medicare Population alone. Cardiovascular disease remains the leading cause of death worldwide, and allowing for widespread usage of echocardiography could result in earlier diagnosis and treatment of cardiovascular disease and potential reduction in healthcare disparities.

The procedure of an echocardiogram first requires image acquisition which is then followed by image analysis and interpretation. Image acquisition is traditionally performed by cardiac sonographers (technicians) or physicians. Image review and interpretation is performed by specialist physicians, typically cardiologists or radiologists. Each step in the process historically requires a high level of training and specialized equipment which limits its use in under-resourced areas. However, given the high level of skill required to operate this equipment there remains a need for additional technologies to aid in the acquisition and interpretation of imaging. As ultrasound technology has improved, however, costs and size of equipment have decreased and use of bedside ultrasound to guide clinical decision making has become increasingly common. This bedside ultrasound is focused on specific questions, such as diagnosis of a pleural or pericardial effusion, and can be readily taught to non-experts.

One of the potential tools to overcome these limitations is artificial intelligence (AI). AI is the use of computer programs to mimic the cognitive function of the human mind in order to learn and solve problems. Echocardiology is a particularly ripe field that may benefit from the use of artificial intelligence. Due to anatomical differences and dynamic clinical situations, the process of image acquisition and analysis can vary widely between patients. Although simple computer algorithms fail to integrate these differences, artificial intelligence may allow for machine-assisted image acquisition and analysis. In the last several years, there have been numerous studies of computer-assisted analysis of echocardiography. The use of this technology may speed the acquisition of echocardiographic images, reduce the amount of training needed to acquire and analyze images, improve diagnostic quality, and reduce interobserver variability in the analysis of echocardiographic images.

By integrating artificial intelligence-assisted image acquisition and analysis with ultrasound technology, it may be possible for minimally trained operators in underserved areas to use echocardiography to accurately diagnose cardiovascular disease.

This study will be supervised by the Echocardiography Laboratory and the Internal Medicine Residency Program in the Department of Medicine at the NewYork Presbyterian Columbia University Medical Center. The study will take place on the medical resident inpatient cardiology ward services which are primarily housed in the Milstein Hospital 5 Garden South ward. The primary subjects of the study are the medical residents in the Department of Medicine who are rotating through the inpatient cardiology ward services.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patients must be admitted to the resident cardiology ward service under a cardiology attending (general, heart failure, or private)
  • •The patient must have either have undergone or be planned to undergo a formal echocardiogram within 1 day of the study echocardiogram
  • •The patient must consent to the study
  • •The patient's inpatient attending physician must give permission for the patient to be approached for consent

Exclusion Criteria

  • •Patient refusal
  • •No recent or planned echocardiogram within 1 day of the study echocardiogram
  • •Clinical need for an emergent echocardiogram that will immediately impact clinical decision making that should instead trigger obtaining a formal echocardiogram (for example, concern for cardiac tamponade or acute myocardial infarction).

Arms & Interventions

Bay Labs EchoGPS group

Experimental

In this arm, medical residents will use the Bay Labs EchoGPS system to perform an echocardiogram.

Intervention: Bay Labs EchoGPS Echcoardiogram (Device)

Native Terason group

Active Comparator

In this arm, medical residents will use the native Terason machine to perform an echocardiogram.

Intervention: Native Terason Echocardiogram (Device)

Outcomes

Primary Outcomes

Echocardiogram image acquisition quality

Time Frame: immediately after the intervention

Echocardiogram image acquisition quality. View quality will be characterized by the following system: adequate (American College of Emergency Physicians (ACEP) score 5), mildly limited (ACEP score 4), moderately limited (ACEP score 3), and severely limited (ACEP score 1 and 2). This will graded for each echocardiogram view as below and for the study as a whole. * Parasternal long axis * Parasternal short axis - aortic valve level * Parasternal short axis - mid ventricle * Apical 4 chamber * Apical 2 chamber * Subcostal - 4 chamber * Subcostal - inferior vena cava

Educational outcome

Time Frame: 1 month

The medical resident's comfort with echocardiography will be established using the following questionnaire. The answers to each question are (1) very uncomfortable, (2) somewhat uncomfortable, (3) somewhat comfortable, and (4) very comfortable. These answers will be reported separately and in aggregate. How comfortable do you feel in your knowledge of the indications for ordering an echocardiogram? How comfortable do you feel in understanding echocardiographic reports as it applies to your patients? How comfortable do you feel in obtaining routine echocardiographic views using an ultrasound machine? How comfortable do you feel in interpreting echocardiographic images after the images have already been obtained? In an emergency situation, how comfortable would you feel in performing an echocardiogram using an ultrasound machine and interpreting the images to rule out serious cardiac pathology such as severe left ventricular systolic dysfunction or a large pericardial effusion?

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kerry Esquitin

Assistant Professor of Medicine

New York Presbyterian Hospital

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