Clinical trial NCT04943965: Testing Automated Echocardiography
Official title: Repeatability, Reproducibility, and Efficacy Testing of Automated Hemodynamic Output by Transthoracic Echocardiography
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Philips Medical Systems
First posted: 2021-06-29
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults undergoing predefined cardiac surgeries

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Correlation Testing Lumify Ultrasound with Hemodynamic Automation
timeFrame: 08/01/2021 - 08/31/2022
measure: Repeatability (intraobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation
timeFrame: 08/01/2021 - 08/31/2022
measure: Reproducibility (interobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation
timeFrame: 08/01/2021 - 08/31/2022
Secondary outcomes:
measure: Clinical Efficacy of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation
timeFrame: 08/01/2022 - 08/31/2023
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania, Department of Anesthesiology and Critical Care
name: Roderic G Eckenhoff, MD
role: STUDY_CHAIR
References: