Testing Automated Echocardiography

NCT04943965 | Completed FDA Device

• 1 other identifier: 848896
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

This Study is Being Conducted to Collect Echocardiographic Data to Test the Lumify Ultrasound With Hemodynamic Automation Device

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Clinical Efficacy of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation

  08/01/2022 - 08/31/2023

Study Arms (2)

Patient undergoing a cardiac surgery

Patients undergoing cardiac surgeries listed in inclusion criteria will be in this group.

Diagnostic Test: Ultrasound imaging

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.

Interventions

Ultrasound imaging DIAGNOSTIC_TEST

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: 1. Pre-induction. 2. Post-induction / Pre-PAC 3. Post-induction / Post-PAC

Also known as: Philips Ultrasound, Lumify Ultrasound, Hemodynamic Automation device

Patient undergoing a cardiac surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults undergoing predefined cardiac surgeries

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Pennsylvania: lead
• Philips Medical Systems: collaborator

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Roderic G Eckenhoff, MD

  University of Pennsylvania, Department of Anesthesiology and Critical Care

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 21, 2021
• First Posted: June 29, 2021
• Study Start: August 11, 2021
• Primary Completion: June 7, 2022
• Study Completion: October 3, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

US (1)