Effect of 3D-printed Reconstruction Automated Matching System in Selecting the Size of Left Double-lumen Tube
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
- the success rates of placement of left DLT without FOB
研究概览
简要总结
The precise and accurate size of DLT is a prerequisite to ensure its accurate position of its placement. Three-dimensional (3D) reconstruction technology can accurately reproduce the tracheobronchial structure to improve the correct size selection of DLT. To make it simpler, the investigators developed an automatic comparison software for 3D reconstruction based on computed tomography data (3DRACS). In this study, the investigators aimed to prove that 3DRACS is much more efficient in endobronchial intubation compared to the traditional method.
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. The investigators 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 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)
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
the success rates of placement of left DLT without FOB
时间窗: After intubation，an average of 2 hours
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
- The time of completing the left DLT's position(After intubation，an average of 2 hours)
- Lung collapse(At 10 and 20 minute after pleurotomy)
- Grading of the airway injury(After extubation，an average of 1 hours)
- Times of using FOB(At the end of surgery.)
- Postoperative sore throat and hoarseness(1, 2 days after surgery)
- Oxygenation during one-lung ventilation(At the end of surgery.)
- The number of the patients who need to change the size of the left DLT(After intubation，an average of 2 hours)
- Appropriate standard for the left DLT(After intubation，an average of 2 hours)
研究者
Yihao Zhu
Clinical Professor
Sichuan Cancer Hospital and Research Institute