A Validation Study to Evaluate the Performance of Caption Health Lung Guidance and Interpretation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 8
- 主要终点
- B-Lines Detection
研究概览
简要总结
The purpose of this study is to assess the efficacy of Caption LungAI.
详细描述
After being informed about the study, all patients giving written informed consent will undergo two 8-zone protocol lung ultrasound exams. One exam will be conducted by an expert lung ultrasound user without Caption LungAI and one exam conducted by a (non-expert) healthcare provider who is trained on Caption LungAI and will use Caption LungAI to capture images.
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
- 否
入选标准
- •Patients over the age of 18
- •Patients presenting to the hospital or outpatient setting with shortness of breath and suspected B-lines.
排除标准
- •Patients in extremis/in whom a research lung ultrasound would not normally be performed due to other priorities
结局指标
主要结局
B-Lines Detection
时间窗: Up to 24 weeks from completion of the study.
Evaluate the product's ability to retrospectively detect present B-lines on images acquired by a local expert with no Caption Lung AI assistance. AUROC \> 0.80; Sensitivity (Se) \> 0.80; Specificity (Sp) \> 0.75
Remote Reader Performance
时间窗: Up to 24 weeks from completion of the study.
Evaluate the product's impact on a remote expert reader's ability to interpret LUS images. Difference Between Aided \& Unaided Groups: AUROC \> 0.00; Sensitivity (Se) \> 0.00; Specificity (Sp) \> 0.00
Diagnostic Image Quality (Trained Healthcare Professional)
时间窗: Up to 24 weeks from completion of the study.
Evaluate the product's ability to assist the user to capture a LUS image with diagnostic quality. Percentage of zones with diagnostic image quality \> 0.80
B-Line Significance
时间窗: Up to 24 weeks from completion of the study.
Evaluate the product's ability to retrospectively detect B-lines of significant severity on images acquired by a local expert with no Caption Lung AI assistance. AUROC \> 0.80; Sensitivity (Se) \> 0.80; Specificity (Sp) \> 0.75
次要结局
- Sub-group Analyses(Up to 24 weeks from completion of the study.)