Augmented Reality Assisted Lung Nodule Localization: a Multicentered, Prospective, Randomly Controlled, Non-inferiority Trial

The surgeon assesses whether effective lung sublobar resection has been achieved intraoperatively. Effective lung sublobar resection is defined as: (1) Completing planned sublobar resection in one session without the need for supplementary segmental or lobar resections; (2) Having a margin distance from the nodule of over 2 cm or at least 1 times the diameter of the nodule. If effective resection is not achieved, the proportion of supplementary segmental or lobar resections will be recorded.

Since the start/end point of CT-guided pulmonary nodule localization may be arbitrary and there may be differences between different researchers, the program duration is derived from the CT scanning parameters and calculated as the length of time between the initial scan and the final scan. The augmented reality (AR) guided positioning time is automatically recorded by the system from the beginning of registration to the completion of positioning.

The time from completion of localization to the start of skin incision for surgery is calculated as the interval time from localization to surgery for both groups.

• CT-guided group: CT-guided localization is performed with the presence of research personnel or assistants to ensure compliance with the study protocol and to collect information on complications on-site. Occurrences of pneumothorax and pulmonary hemorrhage are immediately assessed after localization. Other rare complications such as vasovagal reactions and hemoptysis are also documented. After lung nodule localization, patients are taken to the anesthesia waiting area. During this time, nurses closely monitor the patients for worsening pneumothorax. Any occurrences of hemoptysis or other discomfort are meticulously recorded.
• AR-guided group: Due to the inability to assess pneumothorax and hemoptysis in AR-guided group, the anesthesiologist will be responsible for recording instances of airway bleeding and pneumothorax leading to decreased oxygen levels.

The dose length product (DLP) was used to quantify the total radiation received by patients during the localization of pulmonary nodules. In addition, after the scanning process, the DLP value is directly displayed on the screen of the CT scanner. In order to estimate the relative amount of radiation dose, the effective dose (ED) is also calculated according to the DLP value.

The dislodgement of the hookwire is recorded by the operating surgeon or research assistant intraoperatively. Additionally, due to the impact of nodule depth on dislodgement rate, the distance between the lung nodule and the lung puncture point is also recorded.

The deviation between the hookwire and the target nodule center was evaluated. The deviation is expressed as vertical deviation, anteroposterior deviation and horizontal deviation in three dimensions. The total deviation of nodule localization is calculated as the square root of the sum of squares of each dimension.

The post-localization pain assessment is conducted by the research assistant blindedly on the first day after surgery when the patient is fully awake. The assessment includes evaluating the patient's pain level during the localization process and at the localization site on the first day after surgery using the Numerical Rating Scale (NRS) for scoring. Additionally, pain assessment is repeated on the second day after surgery and again at 30 days after discharge (±7 days).

The post-localization trauma stress disorder assessment is conducted by the research assistant in a blinded manner on the second day after surgery and at 30 days after discharge (±7 days). The Post-traumatic Stress Disorder Checklist - Civilian Version (PCL-C) is used to evaluates the psychological trauma experienced by patients due to the localization procedure.