Application of Intelligent Augmented Reality Glasses in Assisting the Localization of Small Pulmonary Nodules:A Prospective, Randomized, Controlled, Noninferiority Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Accuracy of puncture localization of pulmonary nodules
研究概览
简要总结
This study aims to conduct a large-sample randomized controlled clinical trial, using traditional CT-guided thoracic puncture localization as a comparison, to explore the accuracy, safety and clinical advantages of Intelligent AR glasses in assisting preoperative localizing of small pulmonary nodules.
详细描述
This study is an open-label prospective single-center non-inferiority randomized controlled clinical trial. Patients in the Pulmonary Hospital Affiliated to Tongji University who are scheduled to undergo percutaneous puncture localization of small pulmonary nodules are used as the research subjects. According to the entry and exit criteria Patients were included in the clinical trial, and the enrolled patients were randomly divided into the AR glasses-assisted puncture localizing group (experimental group) and the CT-guided conventional pulmonary nodule puncture localizing group (control group), aiming to evaluate the puncture of pulmonary nodules guided by Intelligent AR glasses. Non-inferiority of localization compared with conventional CT-guided pulmonary nodule puncture localization.
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
- None
盲法说明
no masking
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80, no gender limit;
- •Chest CT shows that the nodule involves the outer third of the lung and can be removed by wedge resection;
- •Chest CT (lung window mode), the maximum diameter of the nodule is ≤2 cm;
- •Physical condition score ECOG 0-2 points;
- •If you plan to undergo percutaneous puncture and localization of small pulmonary nodules, the puncture needle path will be determined by the attending physician;
- •Patients voluntarily participate and sign informed consent.
排除标准
- •The lesion is located in front of the scapula, and the needle path is blocked;
- •The distance between the center of the lesion and the top of the diaphragm is < 3 cm;
- •The lesion is adjacent to the hilus or large blood vessels;
- •Pleural adhesions caused by a history of thoracotomy or pleural infection;
- •The patient voluntarily withdraws midway.
研究组 & 干预措施
AR glasses-assisted pulmonary nodule puncture localization
Combined with placing positioning marks on the patient's body surface and tracing the needle entry point with the assistance of a CT scan gantry laser. Disinfect the area around the puncture needle point, and use 2% lidocaine for local infiltration anesthesia. The doctor wears augmented reality (AR) glasses, completes the connection between the AR glasses and the puncture target, and clicks on the puncture point plane through the puncture target needle tip. Calibrate the puncture position at any two points. After confirming that the patient has held his breath, quickly puncture the needle into the pleura and advance it to the planned puncture position according to the screen prompts. After the second CT scan is performed to confirm that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.
干预措施: AR glasses-assisted pulmonary nodule puncture localization (Procedure)
CT-guided pulmonary nodule puncture localization
Positioning markers are placed on the patient's surface and the first CT scan is performed. The needle insertion point and needle insertion depth are designed based on the two-dimensional CT scan image and the positioning marks. The location of the needle entry point was traced with the laser assistance of the CT gantry. Disinfect and puncture around the needle point, and use 2% lidocaine for local infiltration anesthesia. According to the designed needle path angle, the needle is first inserted under the skin, and a second CT scan is performed to confirm that the extension line of the puncture needle is within the nodule range. Then the needle is inserted to the target depth, and the third CT scan is performed. After confirming that the puncture needle is positioned at a reasonable position, the positioning hook wire is released and the puncture needle sheath is withdrawn.
干预措施: CT-guided pulmonary nodule puncture localization (Procedure)
结局指标
主要结局
Accuracy of puncture localization of pulmonary nodules
时间窗: Intraoperative
Quantified as the shortest distance from the actual position of the puncture needle tip to the originally planned puncture point
次要结局
- Adjust the number of needle punctures(Intraoperative)
- Radiation dose(Intraoperative)
- Success rate of puncture localization of pulmonary nodules(Intraoperative)
- Operating time(Intraoperative)
研究者
Deping Zhao
Administrative Director of Thoracic Surgery Department
Shanghai Pulmonary Hospital, Shanghai, China