Effect of 3D-printed Reconstruction Automated Matching System in Size Selection of Double-lumen Tube：a Prospective Double-blinded Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 主要终点
- Incidence of correct endobronchial intubation.
研究概览
简要总结
Lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients. We have developed an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size and depth of the DLT for lung isolation.The aim of this study was to compare whether the use of 3DRACS to select a DLT size compared to conventional empirical selection methods could improve incidence of DLT intubation success and reduce airway injury.
详细描述
Lung isolation techniques are commonly used to facilitate surgical exposure and to provide single-lung ventilation for patients undergoing various intra-thoracic procedures. Lung isolation is primarily accomplished with a double-lumen tube (DLT) or bronchial blocker. One published study showed that residents with limited experience had a 40% error rate in accurately placing a DLT. The accurate choice of the size of DLT is a prerequisite for good lung isolation.Currently, There is lack of proper objective criteria for selecting size of DLT. DLT size selection is estimated empirically using the patient's height and sex, and studies have shown that the size of DLT according CT images of the chest is more accurate than experience. we have developed an automatic comparison software for 3D reconstruction based on CT data (3DRACS). It reconstructs the trachea and bronchus and compares them with the DLT, predicting the most suitable size and depth of the DLT for lung isolation. The aim of this study was to compare whether the use of 3DRACS to select a DLT size compared to conventional empirical selection methods could improve incidence of DLT intubation success and reduce airway injury.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Two investigators performing intubation of DLT will be blinded to the intervention. All participates and researchers responsible for surgery, bronchoscopy assessment, follow-up, data management and analysis will also be blinded to the grouping.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years.
- •American Society of Anesthesiologists Physical Status (ASA-PS) I-III.
- •Planned to receive lung resection surgery during lung isolation techniques by using DLT.
- •Signed informed written consent.
排除标准
- •The participant experiences any of the following：
- •Spinal malformation,
- •Expected difficult airway
- •Tracheal stenosis
- •Tracheal tumor
- •Bronchial tumor
- •Distorted airway anatomy
- •Tumors of the mouth or neck
结局指标
主要结局
Incidence of correct endobronchial intubation.
时间窗: after intubation
Conventional blindly endobronchial intubation is performed firstly and clinical verification was made by the same anesthesiologist, followed by the supervising anesthesiologist using a FOB to check DLT position and successful intubation was considered if the position was proper.
次要结局
- Oxygenation during one-lung ventilation(Intraoperative（from beginning of one lung ventilation to end），an average of 2 hours)
- Grading of airway injury(When extubation)
- Postoperative sore throat and hoarseness(At 1 hour and 24 hours after extubation)
- Time to successful intubation(after intubation)
- Degree of pulmonary atrophy(after surgery begin)
- Account times of using FOB(During surgery (from induction to extubation), an average of 3 hour)
研究者
Yihao Zhu
Clinical Professor
Sichuan Cancer Hospital and Research Institute