The Use of Lung Ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided Double Lumen Tube: A Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 主要终点
- the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope
研究概览
简要总结
The aim of this study is to compare between The Use of Lung ultrasound, Fluoroscopy and Auscultation to Confirm Proper Positioning of Left Sided DLT in elective thoracic surgeries.
详细描述
A double - blinded randomized controlled trial, After Approval is obtained from research ethics committee of anesthesia and intensive care department, faculty of medicine, Ain Shams University. the study done over18 months. we included patients age between 18 and 60 years old, Physical status according to American Society Anesthesiology 1-3 that will be scheduled for elective thoracic surgery and who required a left-sided double lumen tube (LDLT) during anesthesia after taking written and informed consent. we excluded anticipated difficult intubation, tracheostomy tube, concurrent pneumothorax, pleural effusion, history of pleurodesis, and/or abnormal pulmonary function test (forced expiration volume in one second, total lung capacity, or forced vital capacity < 50% of the predicted values), BMI > 35 kg/m2 , or < 18kg/m2.
a sample size of at least 30 patients per each group of patients undergoing elective thoracic surgery will achieve 100% power, at alpha error 0.05, by using power analysis and sample size software (PASS 15) (Version 15.0.10) for sample size calculation.
Patients will be randomly allocated into 3 groups utilizing computer generated list for allocation and the group assignments will be placed in a closed envelope.
In Group A, the correct position of LDLT during single lung ventilation will be confirmed by clinical methods.
In Group B, the correct position of LDLT during single lung ventilation will be confirmed when lung USG revealed correct lung isolation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-60
- •Physical status: ASA 1-3 that were scheduled for elective thoracic surgery and who required a left-sided double lumen tube (LDLT) during anesthesia after taking written and informed Consent.
排除标准
- •Anticipated difficult intubation.
- •Tracheostomy tube.
- •Concurrent pneumothorax.
- •Pleural effusion and emphysema.
- •History of pleurodesis, and/or abnormal pulmonary function test (forced expiration volume in one second, total lung capacity, or forced vital capacity < 50% of the predicted values).
- •Body mass index more than 35
结局指标
主要结局
the specificity in confirming the position of the LDLT and matching the observation of flexible bronchoscope
时间窗: 2 months after data collection
The findings collected by the three methods will be checked for its specificity by endobronchial bronchoscopy
次要结局
- sensitivity and accuracy in confirming the position of the LDLT.(2 months after data collection)