跳至主要内容
临床试验/NCT07465510
NCT07465510招募中不适用

Ultrasonographic Confirmation of Double-Lumen Endobronchial Tube Placement Compared With Auscultation and Fiberoptic Bronchoscopy in Thoracic Surgery: A Prospective Observational Study

Izmir City Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年1月25日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
Diagnostic accuracy of lung ultrasound for confirmation of double-lumen tube placement

研究概览

简要总结

One-lung ventilation is frequently required in thoracic surgery and is most commonly achieved using double-lumen endobronchial tubes (DLTs). Correct positioning of the DLT is crucial for effective lung isolation and patient safety. Fiberoptic bronchoscopy (FOB) is considered the gold standard for confirming DLT placement; however, it may not always be immediately available and requires specific expertise.

Lung ultrasonography is a rapid, noninvasive, and bedside imaging method increasingly used in anesthesiology and critical care. This prospective observational study aims to evaluate the diagnostic performance of lung ultrasound in confirming the correct position of double-lumen endobronchial tubes in patients undergoing thoracic surgery.

The results obtained from lung ultrasound will be compared with auscultation findings and fiberoptic bronchoscopy results. Fiberoptic bronchoscopy will be considered the reference standard. The sensitivity, specificity, positive predictive value, and negative predictive value of lung ultrasound and auscultation will be calculated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 65 years
  • Scheduled for elective thoracic surgery
  • Planned one-lung ventilation
  • Use of double-lumen endobronchial tube
  • ASA physical status I-III
  • Written informed consent obtained

排除标准

  • Known airway anomalies
  • Previous lung resection surgery
  • Tracheostomy
  • Coagulopathy
  • Pleural effusion or pleural pathology that may interfere with lung ultrasound evaluation
  • Chest wall deformity
  • Emergency surgery
  • Patients who decline participation

研究组 & 干预措施

Thoracic surgery patients undergoing one-lung ventilation with double-lumen tube

Adult patients undergoing elective thoracic surgery requiring one-lung ventilation with a double-lumen endobronchial tube. Tube position will be evaluated using auscultation and lung ultrasound, and confirmed by fiberoptic bronchoscopy as the reference standard.

结局指标

主要结局

Diagnostic accuracy of lung ultrasound for confirmation of double-lumen tube placement

时间窗: Intraoperative (immediately after DLT placement)

Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall diagnostic accuracy of lung ultrasound in confirming correct double-lumen endobronchial tube placement compared with fiberoptic bronchoscopy as the reference standard.

次要结局

  • Agreement between methods(Intraoperative)
  • Diagnostic accuracy of auscultation for confirmation of double-lumen tube placement(Intraoperative)
  • Time required to confirm correct double-lumen tube placement(Immediately after tube placement)
  • Effect of right- versus left-sided double-lumen endobronchial tubes on diagnostic performance(ıntraoperative (immediately after DLT placement))

研究者

发起方
Izmir City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Derya Arslan Yurtlu

Professor Doctor

Izmir City Hospital

研究点 (1)

Loading locations...

相似试验