Repeatability, Reproducibility, and Efficacy Testing of Automated Hemodynamic Output by Transthoracic Echocardiography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Repeatability (intraobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
结局指标
主要结局
Repeatability (intraobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation
时间窗: 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.
Correlation Testing Lumify Ultrasound with Hemodynamic Automation
时间窗: 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.
Reproducibility (interobserver variability) of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation
时间窗: 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.
次要结局
- Clinical Efficacy of hemodynamic parameters obtained from the Lumify Ultrasound with Hemodynamic Automation(08/01/2022 - 08/31/2023)
研究者
Emily MacKay, DO, MSHP
Assistant Professor
University of Pennsylvania