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临床试验/NCT06261411
NCT06261411进行中(未招募)不适用

Effects of Replacing Routine Chest Radiography With Lung Ultrasound for Patients Undergoing Thoracic Surgery: A Randomised Controlled Trial

Uppsala University Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年2月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
140
试验地点
2
主要终点
Reduction in chest x-ray

研究概览

简要总结

This projects aim is to study the effects of substitute conventional chest x-ray with lung ultrasound for patients undergoing thoracic surgery.

Participants in the study will be randomized to either ultrasound or routine chest x-ray as the primary method of diagnosis after having received surgery to their lungs.

详细描述

Modern lung surgery involves a variety of procedures that expose patients to the risk of developing postoperative complications (PPC). In lung surgery such as resections or lobectomies where a part of the lung tissue is removed, so-called single-lung ventilation is used. Through this technique, the lung that is operated on collapses, while ventilation is directed to the lung that is not operated on. When the operation is over, the structures of the lung are sewn together and the collapsed lung is inflated again. At this stage, it is important to ensure that the expansion of the lung is adequate. It is also important for the continued expansion of the lung that there is no air leakage from the lung to the pleural cavity. Therefore, there is initially a drainage in the pleural cavity to prevent both bleeding and air leakage. Postoperatively, several X-ray examinations are performed before the patient is discharged to ensure adequate lung expansion.

Lung ultrasound is a well-established method that is based on physical artifacts that arise in the interaction between ultrasound and various conditions in the lung tissue. The method is used in most of the questions that are usually asked even in chest X-rays and other conventional techniques but has the advantages of being both cost- and time-effective and does not involve the radiation dose that conventional X-rays involve.

The study aims to investigate whether lung ultrasound can replace conventional chest X-rays in patients who have undergone lung surgery. The research subjects will be randomized to undergo postoperative lung ultrasound or conventional chest X-rays after lung surgery.

Previous research has shown the possibility of abandoning X-ray radiation in favor of ultrasound in most scenarios. However, randomized studies are generally lacking, especially in this population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

盲法说明

Inter-rater variability will be masked.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Segmental, partial, or wedge resection lung surgery, or lobectomy.
  • Written informed consent
  • Available research team for measurements.

排除标准

  • Pregnancy
  • Re-surgery due to complications related to the original surgery
  • Need for critical care or admittance to the ICU.
  • Patient or physician choice of withdrawal from the study

研究组 & 干预措施

Lung Ultrasound

Experimental

Lung ultrasound based on specified protocol as primary method of investigation

干预措施: Lung Ultrasound (Diagnostic Test)

Routine Care

No Intervention

Routine care defined as conventional chest x-ray as primary method of investigation

结局指标

主要结局

Reduction in chest x-ray

时间窗: Through patient hospital stay, an average of five days

Reduction in chest x-ray in patients undergoing thoracic surgery when LUS is the primary method of investigation.

次要结局

  • Re-insertion of chest tube(Through patient hospital stay, an average of five days)
  • Delayed removal of chest tube(Through patient hospital stay, an average of five days)
  • Time to chest tube removal(Through patient hospital stay, an average of five days)
  • Patient Satisfaction(Through patient hospital stay, an average of five days)

研究者

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

Sebastian Ullmark

Principal Investigator

Uppsala University Hospital

研究点 (2)

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