NCT07327736

Anesthesia Comparison in Early-stage Small NSCLC: A Multicenter RCT

Comparison Between Spontaneous Breathing-preserving Anesthesia and Double-lumen Endotracheal Intubation Anesthesia in Early-stage Non-small Cell Lung Cancer With a Diameter of ≤ 3 cm: a Prospective, Multicenter Randomized Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Tang-Du Hospital · Academic / Other
• Sex: All
• Age: 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, randomized, controlled study, which intends to enroll patients with suspected early-stage NSCLC (non-small cell lung cancer) with a diameter of ≤ 3 cm as research subjects. The study is conducted in accordance with the Declaration of Helsinki. It has been approved by the Ethics Committee of the Second Affiliated Hospital of Air Force Medical University, and patients or their family members have signed the informed consent form. Patients undergoing VATS (video-assisted thoracic surgery) are enrolled in the Department of Thoracic Surgery of the Second Affiliated Hospital of Air Force Medical University. The patients are randomly divided into two groups: the NIVATS (non-intubated video-assisted thoracic surgery) group and the OLV (one-lung ventilation) group. By observing various perioperative indicators of the patients, the short-term efficacy of the two techniques in patients with early-stage NSCLC is compared, so as to evaluate the safety and effectiveness of the NIVATS surgical treatment method.

Conditions

• Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1

Interventions

Type	Name	Description
PROCEDURE	Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)	NIVATS is a special method developed in the past two decades. It means that patients do not undergo tracheal intubation under general anesthesia during the entire surgical process, retaining their spontaneous breathing, but supraglottic airway devices (such as laryngeal masks, high-flow nasal catheters, mask ventilation) can be used to support their breathing. The purpose of this technology is to minimize the impact of general anesthesia, tracheal intubation, mechanical ventilation, etc. on patients.

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-06-30
• Completion: 2032-12-31
• First posted: 2026-01-08
• Last updated: 2026-03-12