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NCT Number: NCT07327736

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Average postoperative hospital stay

    Time frame: up to 3 months

  2. Intraoperative opioid consumption

    Time frame: 1 day

Secondary outcomes

  1. Lung collapse score

    Time frame: 1 day

  2. Intraoperative blood gas analysis (Q1h)

    Time frame: 1 day

  3. Conversion to intubation rate

    Time frame: 1 day

  4. Postoperative awakening time

    Time frame: 1 day

  5. Time to first ambulation after surgery

    Time frame: up to 3 months

  6. Ambulation rate within 4 hours after surgery

    Time frame: up to 3 months

  7. Inflammatory markers (IL-6, peripheral neutrophil-to-lymphocyte ratio)

    Time frame: up to 3 months

  8. Postoperative drainage volume

    Time frame: up to 3 months

  9. Incidence of perioperative complications

    Time frame: up to 3 months

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  10. 15 item Quality of Recovery Rating Scale (QoR-15)

    Time frame: up to 1 year

Other outcomes

  1. The impact of nursing education on discharge time and time to first ambulation after surgery

    Time frame: up to 3 months

  2. Comparison of the effects of thoracic paravertebral nerve block and intrathoracic intercostal nerve block

    Time frame: up to 3 months

  3. 1-, 3-, and 5-year disease-free survival (DFS)

    Time frame: up to 5 years

  4. 1-, 3-, 5-, and 10-year overall survival (OS)

    Time frame: up to 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

+8615991269383

Sponsors and collaborators

Lead sponsor

Tang-Du Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2032
First posted
Jan 8, 2026
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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