Effects of Replacing Routine Chest Radiography With Lung Ultrasound for Patients Undergoing Thoracic Surgery: A Randomised Controlled Trial
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
- 否
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
Lung ultrasound based on specified protocol as primary method of investigation
干预措施: Lung Ultrasound (Diagnostic Test)
Routine Care
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
Sebastian Ullmark
Principal Investigator
Uppsala University Hospital
