Augmented Reality Navigation Versus Traditional CT Guidance for Preoperative Localization of Pulmonary Nodules
Application of Intelligent Augmented Reality Glasses in Assisting the Localization of Small Pulmonary Nodules:A Prospective, Randomized, Controlled, Noninferiority Trial
Shanghai Pulmonary Hospital, Shanghai, China
166 participants
Mar 14, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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.
Exclusion Criteria5
- 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.
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Interventions
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.
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.
Locations(1)
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NCT06335563