Lung Neoplasms, Mixed Reality
Conditions
Keywords
Lung Neoplasms, Mixed reality, Intraoperative Navigation, Three-Dimensional Imaging
Brief summary
This study is testing whether a new mixed-reality head-mounted display (Apple Vision Pro) can help surgeons see blood vessels more clearly during lung surgery. During the operation, doctors usually need to identify and protect important blood vessels to avoid bleeding. In this study, surgeons will wear the Apple Vision Pro device, which shows 3D images of the lungs and blood vessels. This may help them find vessels more accurately and make surgery safer. Participants scheduled for lung surgery at Huai'an Second People's Hospital will be invited to join. Before the operation, participants will have a CT scan. During surgery, doctors will use the device while performing the procedure. The study does not change the standard surgical steps, and there are no extra risks for participants. The main goal is to see if this new technology makes surgery easier and safer. Participation is voluntary, and all personal information will be kept confidential.
Detailed description
Background: Precise identification of pulmonary blood vessels is critical in thoracic surgery to prevent intraoperative bleeding and complications. Conventional methods rely on direct visual inspection and preoperative imaging review. Recent advances in extended reality (XR) technology offer potential for real-time, three-dimensional visualization during surgery. Objective: This study aims to evaluate the feasibility and safety of using Apple Vision Pro, a mixed-reality head-mounted display, to assist surgeons in identifying and navigating blood vessels during lung surgery. Methods: This is a single-center, prospective clinical study conducted at Huai'an Second People's Hospital. Patients undergoing elective lung surgery will be enrolled. All participants will receive standard preoperative chest CT scans. During surgery, the surgical team will use Apple Vision Pro to visualize reconstructed 3D vascular models superimposed on the surgical field. The primary outcome is the accuracy of vessel identification and navigation. Secondary outcomes include operative time, blood loss, complication rates, and surgeon feedback on usability. Ethical Considerations: The study protocol has been approved by the Medical Ethics Committee of Huai'an Second People's Hospital. Informed consent will be obtained from all participants prior to enrollment. Significance: If successful, this study may provide a novel technological approach to improving surgical precision and safety in thoracic surgery.
Interventions
DEVICEApple Vision Pro
Use of Apple Vision Pro headset for augmented reality-assisted surgical navigation during lung surgery. The device will be worn by the surgeon to visualize critical anatomical structures and navigation pathways in real-time.
Sponsors
The Second People's Hospital of Huai'an
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a single-arm, prospective study. All participants will undergo standard-of-care lung surgery with the addition of the Apple Vision Pro mixed-reality headset for intraoperative vascular navigation. There is no control group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
Patients aged 18 years or older. Diagnosed with lung nodules or early-stage lung cancer requiring surgical resection (lobectomy or segmentectomy). Scheduled for elective lung surgery at Huai'an Second People's Hospital. American Society of Anesthesiologists (ASA) Physical Status Classification I-III. Ability to understand and sign the informed consent form. Willingness to undergo surgery with the Apple Vision Pro navigation assistance.
Exclusion criteria
Patients under 18 years of age. Pregnant or breastfeeding women. Patients with severe cardiopulmonary dysfunction (e.g., severe COPD, unstable angina, recent myocardial infarction) that would contraindicate surgery. Participation in another interventional clinical trial within the past 30 days. Inability to cooperate with the surgical team or follow study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Perivascular Anatomical Identification | During the critical dissection and transection phase of lung surgery | The primary outcome is the accuracy of identifying critical perivascular anatomical structures (including pulmonary arteries, veins, and bronchi) using Apple Vision Pro. Accuracy will be measured by comparing the real-time navigation display with the actual anatomy confirmed by the surgeon during dissection. The primary endpoint is the successful identification of the correct transection plane that avoids injury to adjacent arteries, veins, or bronchi. Any discrepancy leading to potential mis-transection will be recorded. |
Contacts
CONTACTChuxu Wang, Attending Physician
CONTACTBo Min, Associate Professor
PRINCIPAL_INVESTIGATORChuxu Wang, Attending Physician
The Second People's Hospital of Huai'an
Outcome results
None listed