NCT07395375Not yet recruiting
Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection
A Multicenter, Randomized, Controlled Trial of Non-Intubated Spontaneous Breathing Anesthesia Versus Intubated Mechanical Ventilation Anesthesia in Thoracoscopic Sublobar Resection: A Stratified Analysis Study Focusing on Safety and Recovery Quality
Source: ClinicalTrials.gov · Last updated 9 Feb 2026
Brief summary (registry, in English)
This is a large clinical study that compares two different types of anesthesia for patients undergoing a specific kind of minimally invasive lung surgery (thoracoscopic sublobar resection) to remove small, early-stage lung nodules. The study aims to find out if a newer anesthesia method, known as "non-intubated anesthesia" (where patients breathe on their own with the help of a laryngeal mask airway and nerve blocks for pain control), is as safe as the traditional "intubated anesthesia" (which uses a breathing tube and a machine to breathe for the patient). The main goals of the study are, in order: 1. Safety First: To confirm that the non-intubated method does not lead to more lung complications within 30 days after surgery compared to the traditional method. 2. Effectiveness: If it is proven safe, the study will then check if patients receiving the non-intubated anesthesia have a better quality of recovery in the first 24 hours after surgery (e.g., less pain, fewer side effects like a sore throat, and a faster return to normal activities). Approximately 1600 patients from multiple hospitals will be randomly assigned (like flipping a coin) to receive one of the two anesthesia methods. Neither the patients nor the surgeons will be told which group the patient is in when assessing the main outcomes after surgery, to ensure the results are fair and unbiased. The results of this study will provide high-quality evidence to help doctors and patients choose the best and most comfortable anesthesia option for this type of lung surgery.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 1600 (estimated)
- First submitted
- 24 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Diseases
- Lung cancer
- NCT number
- NCT07395375
What you commit to
- Study type: Interventional
- Planned participants: 1600
- From 1 Mar 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Other: Severe hepatic or renal dysfunction, previous ipsilateral thoracic surgery, pregnancy or lactation, active psychiatric or cognitive disorders, or participation in another conflicting clinical trial.
Other illness
- Cardiovascular: NYHA class ≥ III, unstable angina, acute myocardial infarction within 3 months, or severe arrhythmia requiring medication.
- Respiratory: Severe COPD (GOLD 3 or 4), symptomatic interstitial lung disease, resting SpO₂ \< 92% on room air, or severe pulmonary hypertension (estimated systolic PAP \> 50 mmHg).
- Contraindications to Regional Anesthesia: Infection/tumor at the block site, patient refusal, or allergy to local anesthetics.
Lab values
- Coagulopathy: Platelet count \< 100×10⁹/L, INR \> 1.5, or use of anticoagulants that cannot be safely discontinued perioperatively.
Other
- Airway Risk: Modified Mallampati score ≥ 3, mouth opening \< 3 cm, or other predictors of difficult airway management.
- Radiological: Preoperative CT suggesting extensive pleural adhesion, moderate or large pleural effusion, or mediastinal lymph nodes \> 1.5 cm short axis.
Who the study is looking for
- Aged 18 to 80 years (inclusive).
- Scheduled for elective, uniportal or single utility port video-assisted thoracoscopic sublobar resection (wedge resection or simple anatomical segmentectomy).
- Preoperative CT diagnosis of a peripheral pulmonary nodule meeting: maximum diameter ≤ 2.0 cm and outer edge ≤ 2.0 cm from the visceral pleura.
- American Society of Anesthesiologists (ASA) physical status I or II.
- Preoperative pulmonary function: FEV1% ≥ 60% of predicted.
- Preoperative arterial blood gas analysis (room air): PaO₂ ≥ 80 mmHg and PaCO₂ ≤ 45 mmHg.
- Body Mass Index (BMI) between 18.0 and 28.0 kg/m².
- Able to understand the study and provide written informed consent.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affiliated Hospital of GZMU Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.