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

NCT07327736 | Not Yet Recruiting

• 1 other identifier: IIT202508-17-KYB-15-XWK
• Study Type: interventional
• Target: 410
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (2)

• Average postoperative hospital stay

  up to 3 months

• Intraoperative opioid consumption

  1 day

Secondary Outcomes (10)

• 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

Other Outcomes (4)

• 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

Study Arms (2)

group A

EXPERIMENTAL

Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)

Procedure: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)

group B

PLACEBO COMPARATOR

Tracheal Intubation with One-Lung Ventilation Group (OLV)

Procedure: Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS)

Interventions

Non-intubated video-assisted thoracic surgery with spontaneous breathing (NIVATS) PROCEDURE

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.

group A; group B

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tang-Du Hospital: lead

Related Publications (8)

• 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.

  PMID: 15511470 BACKGROUND

• 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.

  PMID: 25489580 BACKGROUND

• 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.

  PMID: 34765639 BACKGROUND

• 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.

  PMID: 26197368 BACKGROUND

• 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.

  PMID: 30763562 BACKGROUND

• 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.

  PMID: 28320572 BACKGROUND

• 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.

  PMID: 34938770 BACKGROUND

• 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.

  PMID: 26046043 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Xiaolong Yan, Doctor of Medicine (M.D.)

CONTACT

+8615991269383; yanxiaolong@fmmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: January 8, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2032
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share