跳至主要内容
临床试验/NCT04891094
NCT04891094已完成不适用

Lung and Diaphragm Ultrasound in the Early Postoperative Course Following Lung Transplantation

Ludwig-Maximilians - University of Munich2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年4月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
The value of LUS in diagnosing PGD

研究概览

简要总结

This feasibility study tries to define the value of daily Lung and Diaphragm Ultrasound in the early postoperative course following Lung transplantation by comparing its diagnostic accuracy with that of standard of care diagnostic procedures

详细描述

Lung transplantation remains a high risk procedure. Common complications in the early postoperative course are, among others, primary graft dysfunction (PGD), hemorrhage, anastomosis insufficiency leading to pneumothorax, pneumonia, atelectasis and diaphragm dysfunction. Early diagnosis of complications is important to avoid further deterioration. Lung ultrasound (LUS) and diaphragm ultrasound (DUS) has a high diagnostic accuracy for identifying frequent conditions in the critically ill. Studies evaluating its value in patients following lung transplantation are missing. This study investigates the feasibility and clinical ability of LUS and DUS to identify common complications following lung transplantation and compares it to standard of care diagnostic procedures. The investigators start a prospective cohort study of lung transplant recipients who undergo lung transplantation at the university hospital Munich. Daily LUS and DUS in the early postoperative phase will be performed to detect and monitor complications. The US results will be compared to the results of diagnostic procedures of the clinical routine such as clinical examination, chest x ray, hemodynamic monitoring, expert opinion on PGD and laboratory parameters.

The hypothesis is that daily LUS and DUS following lung transplantation helps to diagnose complications early and with higher accuracy compared to the results of diagnostic procedures of the clinical routine.

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 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • informed consent
  • patient following lung transplantation

排除标准

  • no informed consent

结局指标

主要结局

The value of LUS in diagnosing PGD

时间窗: postoperative day 3

number of days with PGD in LUS versus standard of care

Is Lung Sliding reliable in the early postoperative course following lung transplantation?

时间窗: postoperative day 3

Number of days with detectable lung sliding in LUS. Number of days with detectable pneumothorax in LUS.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Michael Zoller MD

Clinical Professor

Ludwig-Maximilians - University of Munich

研究点 (2)

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