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

Tang-Du Hospital

Status: Not yet enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07327736

IIT202508-17-KYB-15-XWK

Details and patient eligibility

About

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.

Enrollment: 410 estimated patients

Sex: All

Ages: Under 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

410 participants in 2 patient groups, including a placebo group

group A

Experimental group

Description:

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

Treatment:

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

group B

Placebo Comparator group

Description:

Tracheal Intubation with One-Lung Ventilation Group (OLV)

Treatment:

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