Study for Point-of-Care Echocardiography With Assistance Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Study-level Assessment
研究概览
简要总结
Establish the effectiveness of the Bay Labs, Inc. EchoGPS software in enabling RNs to acquire echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).
详细描述
To validate clinical use of Bay Labs, Inc. EchoGPS guidance software by registered nurses (RNs) with no prior scanning experience to acquire limited two-dimensional echocardiograms. In this study an echocardiogram protocol using the EchoGPS interface with the Terason uSmart 3200t, an FDA 510(k)-cleared, commercially available ultrasound device will be performed. Participants will have two scans, one by a registered nurse (RN) using the Terason uSmart 3200t with EchoGPS (Study Exam) and one by a sonographer using the Reference Device without EchoGPS guidance (Control Exam), under the same protocol. Study is non-significant risk (NSR).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All patients must meet the following inclusion criteria to participate in the study:
- •Patients scheduled for an echocardiographic examination
- •Patients ≥18 years old
排除标准
- •Patients must NOT meet any of the following exclusion criteria to participate in the trial:
- •Unable to lie flat for study
- •Patients experiencing a known or suspected acute cardiac event
- •Patients with severe chest wall abnormalities
- •Patients who have undergone pneumonectomy
- •Patients unwilling or unable to give written informed consent
研究组 & 干预措施
Patients scheduled for an echocardiogram
Patients ≥18 years scheduled for an echocardiographic examination. This is a non-randomized, un-blinded, study in patients with an indication for an echocardiographic examination. Enrolled patients will be stratified into two groups based on known cardiac abnormalities to ensure a sufficient number of patients with cardiac abnormalities and into 3 strata of BMI: normal, overweight and obese.
干预措施: Diagnostic Test: Limited Echocardiogram (Diagnostic Test)
结局指标
主要结局
Study-level Assessment
时间窗: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
The primary endpoints for the study are separate patient-level assessments of whether the patient study is of adequate image quality to make a qualitative visual assessment for a particular clinical parameter (ie., Yes/No). Expert cardiologist readers will independently provide assessments and they will be blinded to the assessments from the other readers as well as whether the images were acquired by an RN or sonographer. The Outcome Measure will be reported as the percentage of patient studies for which the panel of cardiologist readers adjudicated as being of sufficient image quality to make a particular clinical assessment.
次要结局
- View-level Assessment(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- Inter-User Variability (Primary Clinical Parameters)(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- Inter-User Variability (Acquisition Time)(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- Patient-Level Acquisition time(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- View-Level Acquisition time(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- Comparison of study exam and control exam (View-Level Results)(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- Comparison of study exam and control exam (Patient-Level Results)(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- Comparison of study exam and control exam (Task-Based Assessment)(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
研究者
Sara Guttas
Clinical Applications Manager
Caption Health, Inc.