Kosmos Trio and Ejection Fraction Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 1
- 主要终点
- Assessment of Right Ventricular Size
研究概览
简要总结
This is a single-group, observational study which will involve obtaining two echo scans of recruited patients. All recruited patients will undergo echo scans by both novice users (nurses) and experts (echo sonographers). Image quality between novices and experts as well as the ability to calculate LVEF from novice and expert scans and the quality of the LVEF calculated via KOSMOS-EF compared to LVEF calculations by expert cardiologists will occur in post-hoc Echo image analysis
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 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 18-89 years of age
- •Have capacity to provide written consent either themselves or via healthcare proxy as determined by subjects' clinical care teams
- •Have an anticipated timeline in the EDOU long enough to allow for completion of study procedures without causing delay to subjects' usual clinical care
排除标准
- •Heart rate > 110 beats per minute at the time of recruitment
- •Pregnant women
- •Prior chest surgery
- •Chest wall deformities or injuries (i.e. wounds, infections, etc)
- •Limited mobility precluding them from turning in bed independently
- •Speak a primary language other than English or Spanish
- •Vulnerable populations including: patients being evaluated for psychiatric crises, incarcerated individuals
- •Unwilling or unable to consent to study procedures
结局指标
主要结局
Assessment of Right Ventricular Size
时间窗: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Right Ventricle Size.
Assessment of Global Left Ventricular Function
时间窗: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurses is of sufficient image quality to make a qualitative visual assessment of the Global Left Ventricular Function.
Assessment of Left Ventricular Size
时间窗: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of the Left Ventricular Size.
Assessment of Non-Trivial Pericardial Effusion
时间窗: Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments
A panel of cardiologists will access and determine via a majority vote if a study exam acquired by a nurse is of sufficient image quality to make a qualitative visual assessment of Non-Trivial Pericardial Effusion.
次要结局
- Assessment of Automatic Structure Labelling(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- Manual vs. KOSMOS-EF for Sonographer Scans(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)
- Assessment of Left Atrial Size(Up to 2 months from the completion of the study or when all expert cardiologists readers independently complete their assessments)