NCT04203251Unknown不适用
Evaluation of TTE Utilization in Medical Surgery Step-Down Unit: Use of AI Assisted Point-of-Care Echo With Guidance Technology
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of attempted studies with clinically useful images
研究概览
简要总结
This is a non-randomized, un-blinded study to evaluate Caption Health guidance software in patients in the medical surgery step-down unit. Patients will be scanned by a trained hospitalist and up to 4 standard views will be obtained per participant: PLAX, PSAX-PM, AP4 and SubC4. Observations will be made regarding human factors and performance of the device.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥18 years old
- •Patients in the medical surgery step-down clinical setting
- •Patients who consent to participating in the study
排除标准
- •● Patients with emergent or urgent episodes of injury and illness that can lead to death or disability without rapid intervention
- •Unable to lie flat for study
- •Patients experiencing a known or suspected acute cardiac event at the time of evaluation
- •Patients with severe chest wall abnormalities
- •Patients who have undergone pneumonectomy
- •Patients with recent abdominal surgery
- •Patients unwilling or unable to give written informed consent
- •Principal Investigator determination to exclude the subject from participation
- •Investigators also have the right to withdraw patient from the study in the event of illness, adverse events, or other reasons concerning the health or well-being of the patient, or in the case of non-compliance.
结局指标
主要结局
Percentage of attempted studies with clinically useful images
时间窗: Up to 3 Months
Compare the percentage of clinically useful versus not useful images
Mean time to acquire images
时间窗: Up to 3 months
Assess the time to acquire cardiac ultrasound images with and without Caption AI Gudiance
次要结局
未报告次要终点
研究者
研究点 (1)
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