Point of Care Lung Ultrasound Examination in Patients With Shortness of Breath
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment
研究概览
简要总结
This is a prospective, non-randomized clinical validation research study. Subjects will consent and have two ultrasounds as part of the study.
详细描述
This study is to collect data to validate the performance of Caption Lung AI in enabling trained healthcare professionals to perform LUS to obtain diagnostic-quality Lung Ultrasound Studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients over the age of 22; AND
- •2. Patients with known lung pathology or patients with no known lung pathology in the hospital or presenting to the hospital or outpatient setting with shortness of breath.
排除标准
- •1. Patients in extremis and/or patients in whom a lung ultrasound would not normally be performed;
- •2. Patients who are unable to consent;
- •3. Patients who are prisoners; AND
- •4. Patients who do not speak English fluently.
研究组 & 干预措施
Cohort 1 -Device 1
Cohort 1 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform an 8-zone lung ultrasound (LUS) exam.
The Trained HCP will be required to capture at least 2 clips per zone using an ultrasound with Caption AI before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam).
The Expert LUS user will use the same ultrasound system but without Caption Lung AI (Control Exam).
干预措施: Lung ultrasound (Device)
Cohort 2 -Device 2
Cohort 2 will utilize the Venue GO ultrasound system to perform a 12-zone lung ultrasound (LUS) exam.
All Qualified users using Caption Lung AI will be required to capture at least 2 clips per zone before moving onto the next zone. The scanner can capture multiple clips per zone, via-auto-capture or Save Best Clip (Study Exam).
The Qualified user will use the same ultrasound system but without Caption Lung AI (Control Exam).
干预措施: Lung ultrasound (Device)
Cohort 0 - Vscan (no AI)
Cohort 0 will utilize the Vscan Air CL (curvilinear and linear probes) and SL (sector probe) handheld ultrasound to perform the following lung ultrasound (LUS) exams.: Each patient will undergo 2 8-zone lung examinations which will be a combination of the enrollment distribution listed below equating to up to 30 subjects with 2 scans per subject (60 scans).
干预措施: Lung ultrasound (Device)
结局指标
主要结局
Cohort 1: % of patient studies composed of images acquired by the THCPs with sufficient quality to make a clinical assessment
时间窗: 7 months
The primary endpoint will be based on the majority assessment of the independent expert readers qualitatively assessment of the LUS exam (study level) as being of diagnostic quality.
Cohort 2: % of patient studies composed of images acquired by the Qualified user to make a clinical assessment
时间窗: 7 months
The primary endpoint will be based on the majority assessment of the independent expert readers qualitatively assessment of the LUS exam (study level) as being of diagnostic quality.
次要结局
- Cohort 1:(7 months)
- Cohort 2:(7 months)
- Cohort 1:(7 months)
- Cohort 1 and 2:(7 months)
- Cohort 1 and 2:(7 months)