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临床试验/NCT03314519
NCT03314519已完成不适用

A Randomized Controlled Study Compare Lung Ultrasonography to Fiberoptic Bronchoscopy Confirming Double Lumen Tube Positioning for Thoracic Surgery.

Mahidol University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年10月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy

研究概览

简要总结

The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as the standard test.

详细描述

The study contains the result from a comparison of diagnostic outcomes about lung collapse by using lung ultrasonography as a new diagnostic test compares to fiberoptic bronchoscopy as a standard test. Both of them detect lung collapse reported as surgical grading lung collapse by the thoracic surgeons. The protocol was performed in a randomized controlled trial whether the subject was allocated to the ultrasonography group or the fiberoptic bronchoscopy group.

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
Triple (Participant, Care Provider, Outcomes Assessor)

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

  • •Adult patients, age ≥18 years old
  • •American Society of Anesthesiologists(ASA) physical status classification I - III
  • •Scheduled for elective thoracic surgery which requires One lung ventilation(OLV) with Left-sided double lumen tube

排除标准

  • •Anticipated difficult intubation or with the tracheostomy tube
  • •Patient with pneumothorax, pleural effusion, emphysema or past history of pleurodesis
  • •Patient with deranges pulmonary function test (out of forced expiration volume in 1 s, total lung capacity, forced vital capacity <50% of the predicted values)
  • •The patient refuses to participate.

研究组 & 干预措施

Ultrasonography

Experimental

Patients in this group receive lung ultrasonography to detect lung collapse after insert double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering pleural cavity.

干预措施: Lung ultrasonography by experienced anaesthesiologist (Diagnostic Test)

Fiberoptic bronchoscopy

Active Comparator

Patients in this group receive fiberoptic bronchoscope to detect lung collapse after inserting a double lumen tube and finally compare lung collapse by the surgeon's visual grading scale of lung collapse when entering the pleural cavity.

干预措施: Fiberoptic bronchoscopy for double lumen tube's position (Diagnostic Test)

结局指标

主要结局

Number of Patients of Lung Collapse in Ultrasonography and Fiberoptic Bronchoscopy

时间窗: 30 minutes

Compare number of patients with lung collapse detected by ultrasonography and fiberoptic bronchoscopy in patient with double lumen tube by report as specificity and sensitivity of detection of lung collapse by compare to visual grading of lung collapse by surgeon

次要结局

  • Timing to Detect Lung Collapse(30 minutes)
  • Accuracy of Detection of Lung Collapse in Ultrasonography Method in Cardiovascular and Thoracic Anesthesia Fellow(30 minutes)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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