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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Patients With Suspected Non-small Cell Lung Cancer (NSCLC) at Clinical Stage T1
• Intervention / Treatment: Procedure: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)

• Study Type: Interventional
• Enrollment (Estimated): 410
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaolong Yan, Doctor of Medicine (M.D.); Phone Number: +8615991269383; Email: yanxiaolong@fmmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≤ 75 years;
• Gender is not limited;
• Patients with suspected T1 stage non-small cell lung cancer (NSCLC) in preoperative clinical staging, with thin-slice CT showing that the maximum tumor diameter is ≤ 3.0 cm, single or multiple nodules, and the nodules requiring surgical resection are located in the same ipsilateral lung lobe, with the number of nodules resected simultaneously ≤ 3;
• American Society of Anesthesiologists (ASA) classification ≤ Grade III (preferably Grade I - II is recommended);
• Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1;
• Body Mass Index (BMI) < 25 kg·m-²;
• Normal cardiopulmonary function: predicted forced expiratory volume in the first second (FEV1%) > 50%, resting blood gas analysis showing arterial oxygen partial pressure (PaO2) ≥ 75 mmHg, arterial carbon dioxide partial pressure (PaCO2) < 45 mmHg; ejection fraction (EF) > 50%, 6-minute walk distance (6MWD) ≥ 350 m;
• No severe upper airway lesions, Mallampati classification I - II;
• No contraindications related to paravertebral nerve block and intercostal nerve block;
• Estimated surgical time ≤ 150 minutes;
• Patients have no history of clinically significant cardiac or neurological problems.

Exclusion Criteria:

• A history of ipsilateral lung surgery;
• Interstitial pneumonia, pulmonary fibrosis, severe emphysema, severe chronic obstructive pulmonary disease, acute phase of pulmonary infection, or uncontrolled asthma;
• Sleep apnea syndrome with anticipated airway difficulty or difficulty in airway management;
• Preoperative complications including coagulation dysfunction, hypoxemia, hypercapnia, or hepatic/renal insufficiency;
• Alteration of anesthesia or surgical plan;
• Persistent cough or increased risk of high airway secretion reflux;
• Mental disorders, inability to communicate, or refusal to sign the informed consent form;
• Participation in other clinical trials within 1 month before this trial;
• Those who are deemed unfit to participate in this trial by the researchers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)	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.
Placebo Comparator: group B; Tracheal Intubation with One-Lung Ventilation Group (OLV)	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average postoperative hospital stay	up to 3 months
Intraoperative opioid consumption	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung collapse score		1 day
Intraoperative blood gas analysis (Q1h)		1 day
Conversion to intubation rate		1 day
Postoperative awakening time		1 day
Time to first ambulation after surgery		up to 3 months
Ambulation rate within 4 hours after surgery		up to 3 months
Inflammatory markers (IL-6, peripheral neutrophil-to-lymphocyte ratio)		up to 3 months
Postoperative drainage volume		up to 3 months
Incidence of perioperative complications	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	up to 3 months
15 item Quality of Recovery Rating Scale (QoR-15)		up to 1 year

Other Outcome Measures

Outcome Measure	Time Frame
The impact of nursing education on discharge time and time to first ambulation after surgery	up to 3 months
Comparison of the effects of thoracic paravertebral nerve block and intrathoracic intercostal nerve block	up to 3 months
1-, 3-, and 5-year disease-free survival (DFS)	up to 5 years
1-, 3-, 5-, and 10-year overall survival (OS)	up to 10 years

Collaborators and Investigators

• Sponsor: Tang-Du Hospital

Publications and helpful links

General Publications

• Pompeo E, Mineo D, Rogliani P, Sabato AF, Mineo TC. Feasibility and results of awake thoracoscopic resection of solitary pulmonary nodules. Ann Thorac Surg. 2004 Nov;78(5):1761-8. doi: 10.1016/j.athoracsur.2004.05.083.
• Pompeo E. State of the art and perspectives in non-intubated thoracic surgery. Ann Transl Med. 2014 Nov;2(11):106. doi: 10.3978/j.issn.2305-5839.2014.10.01.
• Chiang XH, Lin MW. Converting to Intubation During Non-intubated Thoracic Surgery: Incidence, Indication, Technique, and Prevention. Front Surg. 2021 Oct 26;8:769850. doi: 10.3389/fsurg.2021.769850. eCollection 2021.
• Lohser J, Slinger P. Lung Injury After One-Lung Ventilation: A Review of the Pathophysiologic Mechanisms Affecting the Ventilated and the Collapsed Lung. Anesth Analg. 2015 Aug;121(2):302-18. doi: 10.1213/ANE.0000000000000808.
• Hung WT, Hung MH, Wang ML, Cheng YJ, Hsu HH, Chen JS. Nonintubated Thoracoscopic Surgery for Lung Tumor: Seven Years' Experience With 1,025 Patients. Ann Thorac Surg. 2019 Jun;107(6):1607-1612. doi: 10.1016/j.athoracsur.2019.01.013. Epub 2019 Feb 11.
• Gelzinis TA, Sullivan EA. Non-Intubated General Anesthesia for Video-Assisted Thoracoscopic Surgery. J Cardiothorac Vasc Anesth. 2017 Apr;31(2):407-408. doi: 10.1053/j.jvca.2016.12.027. Epub 2016 Dec 23. No abstract available.
• Janik M, Juhos P, Lucenic M, Tarabova K. Non-intubated Thoracoscopic Surgery-Pros and Cons. Front Surg. 2021 Dec 6;8:801718. doi: 10.3389/fsurg.2021.801718. eCollection 2021.
• Liu J, Cui F, He J. Non-intubated video-assisted thoracoscopic surgery anatomical resections: a new perspective for treatment of lung cancer. Ann Transl Med. 2015 May;3(8):102. doi: 10.3978/j.issn.2305-5839.2015.04.18.

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2032

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 25, 2025
• First Posted (Actual): January 8, 2026

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: IIT202508-17-KYB-15-XWK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No