Testing Automated Echocardiography

Repeatability, Reproducibility, and Efficacy Testing of Automated Hemodynamic Output by Transthoracic Echocardiography

The purpose of this research is to determine if software can accurately predict certain heart parameters from chest wall ultrasound (non-radiation, non-invasive, imaging modality). An approved ultrasound device (Lumify) will be used to obtain images prior to cardiac surgery.

Study Overview

• Status: Completed
• Conditions: This Study is Being Conducted to Collect Echocardiographic Data to Test the Lumify Ultrasound With Hemodynamic Automation Device
• Intervention / Treatment: Diagnostic test: Ultrasound imaging

Detailed Description

This is a prospective, non-randomized, single visit clinical study. No additional interventions or follow-ups to the subject will be conducted as part of the study. All investigational scanning will be conducted using the as low as reasonably achievable (ALARA) principle to ensure the safety of the subjects. As ultrasound imaging is based on non-ionizing radiation, it is generally considered safe when used by appropriately trained health care providers. The study population will be adults. There are no specific enrollment targets, however it is expected that 120 subjects or fewer will be scanned to obtain the required 40 echocardiographic exams to complete this study. Exceeding the enrollment target of 120 subjects will require an amendment to the protocol. It is estimated this study will last for 12 months, at that time it will be evaluated and may potentially be amended.

This study is considered non-significant risk. There is no specific benefit to individuals participating in the study, however the feedback received is used to improve Philips systems and that can lead to increased diagnostic ability in future products.

• Study Type: Observational
• Enrollment (Actual): 35

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing predefined cardiac surgeries

Description

Inclusion Criteria:

• Patient willing and capable of providing informed consent and physically capable of performing study related activities
• Patient undergoing any of the following types of cardiac surgeries:

Aortic valve repair Aortic valve replacement Mitral valve repair Mitral valve replacement Tricuspid valve repair Tricuspid valve replacement Pulmonic valve repair Pulmonic valve replacement Ascending aorta replacement Coronary Artery Bypass Graft (CABG) surgery

Exclusion Criteria:

• Pregnant women
• Patients known to be under the jurisdiction of the Department of Corrections
• Patients with persistent arrhythmias as confirmed by the principal investigator (MacKay) on a caseby-case basis (e.g. atrial fibrillation, atrial flutter, frequent premature ventricular contractions, frequent premature atrial contractions, etc.)
• Patients with a contraindication to Pulmonary Arterial Catheter (PAC) monitoring as confirmed by the principal investigator (MacKay) on a case-by-case basis (e.g. tricuspid or pulmonic valve endocarditis, venous thrombosis present in the superior vena cava, right atrium, or main pulmonary artery)
• Patients with a contraindication to TEE monitoring as confirmed by the principal investigator (MacKay) on a case-by-case basis (e.g. previous esophageal surgery, prior gastric bypass surgery, esophageal varices).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient undergoing a cardiac surgery; Patients undergoing cardiac surgeries listed in inclusion criteria will be in this group.	Diagnostic test: Ultrasound imaging; The intervention is non-invasive, chest wall, echocardiographic image acquisition in the cardiac operating room prior to a scheduled cardiac surgery. Echocardiographic images will be taken at three, key, timepoints in the operating room prior to cardiac surgery: Pre-induction.; Post-induction / Pre-PAC; Post-induction / Post-PAC; Other Names: Philips Ultrasound; Lumify Ultrasound; Hemodynamic Automation device
Clinicians; Clinicians defined as physicians (e.g. attendings, fellows, residents) or advanced practice providers (e.g. nurse practitioners and physician assistants) will be in this group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation Testing Lumify Ultrasound with Hemodynamic Automation	Correlation between the hemodynamic parameters (e.g. stroke volume, cardiac output, cardiac index) obtained from the Lumify Ultrasound with Hemodynamic Automation with same hemodynamic parameters obtained from the reference standard of transesophageal echocardiography and pulmonary arterial catheterization by a single echocardiographer.	08/01/2021 - 08/31/2022
Repeatability (intraobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation	Repeatability of the hemodynamic parameters (e.g. stroke volume, cardiac output, cardiac index) obtained from the Lumify Ultrasound with Hemodynamic Automation at set time intervals of one minute by a single echocardiographer.	08/01/2021 - 08/31/2022
Reproducibility (interobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation	Reproducibility of the hemodynamic parameters (e.g. stroke volume, cardiac output, cardiac index) obtained from the Lumify Ultrasound with Hemodynamic Automation at set time intervals of one minute by a multiple echocardiographers blinded to each other's data.	08/01/2021 - 08/31/2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Efficacy of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation	Clinician providers will evaluate the clinical efficacy of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation by survey questions directly comparing the Lumify echocardiographic imaging to the reference standard	08/01/2022 - 08/31/2023

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: Philips Medical Systems
• Investigators: Study Chair: Roderic G Eckenhoff, MD, University of Pennsylvania, Department of Anesthesiology and Critical Care

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): June 7, 2022
• Study Completion (Actual): October 3, 2023

Study Registration Dates

• First Submitted: June 21, 2021
• First Submitted That Met QC Criteria: June 21, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Ultrasound; Imaging; Cardiac Surgery; Mitral valve repair; Coronary Artery Bypass Graft; Mitral valve replacement; Aortic valve replacement; Tricuspid valve replacement; Philips Ultrasound; Lumify Ultrasound; Hemodynamic Automation device; Lumify Ultrasound with Hemodynamic Automation; Automated hemodynamic output; Point-of-care echocardiographic imaging; Aortic valve repair; Tricuspid valve repair; Pulmonic valve repair; Pulmonic valve replacement; Ascending aorta replacement
• Other Study ID Numbers: 848896

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes