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OpenTrials
Completed

NCT Number: NCT04943965

Testing Automated 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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:

  • Pre-induction.
  • Post-induction / Pre-PAC
  • Post-induction / Post-PAC

Other names: Philips Ultrasound, Lumify Ultrasound, Hemodynamic Automation device

Primary outcomes

  1. Correlation Testing Lumify Ultrasound with Hemodynamic Automation

    Time frame: 08/01/2021 - 08/31/2022

    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.

  2. Repeatability (intraobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation

    Time frame: 08/01/2021 - 08/31/2022

    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.

  3. Reproducibility (interobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation

    Time frame: 08/01/2021 - 08/31/2022

    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.

Secondary outcomes

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

    Time frame: 08/01/2022 - 08/31/2023

    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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Philips Medical Systems

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 29, 2021
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.