Application of Lung Ultrasound Artefact Analysis for Exclusion of Acute Rejection in Asymptomatic Lung Transplant Recipients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Establish predictive value of lung ultrasound
研究概览
简要总结
This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.
详细描述
Lung transplant recipients are at high risk for lung rejection and lung infection after transplant. This is diagnosed by performing lung bronchoscopies and lung biopsies. These procedures carry an increased risk for complications and are costly. This study is being done to study a safe and non-invasive way to diagnose lung rejection and infection.
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
盲法说明
This study is not blinded
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
- •Adult patients (> 18 yrs) who had undergone single/double/heart-lung transplant
- •Asymptomatic
- •Normal spirometry defined as a FEV1 without significant drop from baseline (significant drop = >10% decrease from baseline)
- •Clear chest radiograph over allograft
排除标准
- •Patients who are unable to consent for the procedure
- •Patients with subcutaneous emphysema or other technical challenges that could interfere with satisfactory image acquisition- as deemed by the operator.
研究组 & 干预措施
Receiving Ultrasound
Every patient will receive a lung ultrasound prior to each scheduled bronchoscopy until the study stops.
干预措施: Lung ultrasound (Diagnostic Test)
结局指标
主要结局
Establish predictive value of lung ultrasound
时间窗: Month 0 to month 12
Determine if lung ultrasound provides the same diagnostic results as bronchoscopy and biopsy
次要结局
未报告次要终点
研究者
Tathagat Narula
Principal Investigator
Mayo Clinic