An interventional study of Non-intubated Anesthesia and Conventional Intubated General Anesthesia in Pulmonary Nodules, Lung Neoplasms and Thoracic Surgery, sponsored by The First Affiliated Hospital of Guangzhou Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-09.
Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment
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:
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.
99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.
This study's planned enrollment of 1,600 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.
Browse Multiple Pulmonary Nodules studies →The First Affiliated Hospital of Guangzhou Medical University is the lead sponsor of 167 studies on the registry; 69 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients randomized to this group will receive the experimental intervention, non-intubated spontaneous breathing anesthesia. The key components include: Airway Management: A laryngeal mask airway will be used instead of an endotracheal tube. Anesthesia Technique: Intravenous sedation will be administered to maintain spontaneous breathing, combined with regional nerve blocks (e.g., paravertebral or intercostal block) for analgesia. Goal: This approach aims to avoid the potential trauma and lung injury associated with double-lumen tube intubation and mechanical ventilation. A predefined set of safety criteria for conversion to intubated anesthesia (e.g., low oxygen levels, excessive carbon dioxide buildup) will be strictly followed during the procedure.
Procedure: Non-intubated Anesthesia · Device: Laryngeal Mask Airway (LMA) · Drug: Intravenous Sedation/Anesthesia (Spontaneous Ventilation) · Drug: Regional Nerve Block (Paravertebral/Intercostal Block)
Patients randomized to this group will receive the current standard of care for thoracoscopic lung surgery, which is conventional intubated general anesthesia. The intervention consists of: Airway Management: Double-lumen endobronchial tube intubation to achieve one-lung ventilation. Anesthesia Technique: Standard general anesthesia with muscle relaxation and controlled mechanical ventilation. This approach represents the well-established, traditional method against which the experimental non-intubated anesthesia is being compared.
Procedure: Conventional Intubated General Anesthesia · Device: Double-lumen Endotracheal Tube (DLT) · Drug: General Anesthesia With Neuromuscular Blockade
A novel anesthetic technique for thoracic surgery that avoids endotracheal intubation and mechanical ventilation. It typically involves intravenous sedation, the use of a laryngeal mask airway (LMA) for oxygenation, and regional nerve blocks (e.g., paravertebral block) for pain control. The key feature is the preservation of the patient's spontaneous breathing throughout the surgical procedure.
The current standard anesthetic technique for thoracoscopic surgery. It involves general anesthesia induced by intravenous agents, followed by the insertion of a double-lumen endotracheal tube to achieve one-lung ventilation. Anesthesia is maintained with inhalational or intravenous agents, and the patient's ventilation is fully controlled by a mechanical ventilator throughout the operation.
Airway management using a laryngeal mask airway to maintain spontaneous ventilation during thoracoscopic surgery.
Intravenous sedative/anesthetic agents administered to achieve adequate anesthesia while preserving spontaneous breathing.
Regional anesthesia with local anesthetic (e.g., paravertebral or intercostal block) for perioperative analgesia.
Double-lumen endotracheal tube used to achieve one-lung ventilation during general anesthesia.
General anesthesia maintained with intravenous and/or inhalational agents with muscle relaxation for controlled mechanical ventilation.
Incidence of composite perioperative complications
This primary outcome measures the incidence of a composite of postoperative pulmonary complications (PPCs) within 30 days after surgery. The composite endpoint includes the occurrence of any one of the following predefined complications: pneumonia, respiratory failure, atelectasis requiring bronchoscopy, acute lung injury (ALI)/acute respiratory distress syndrome (ARDS), pulmonary embolism, bronchopleural fistula, pleural effusion requiring drainage, or pneumothorax requiring intervention. The assessment period begins at anesthesia induction and concludes 30 days post-surgery.
Time frame: From anesthesia induction up to 30 days after surgery
Postoperative recovery quality assessed by the QoR-15 score
This primary outcome measures the quality of patient recovery at 24 hours after surgery using the validated Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 score encompasses 15 items across five dimensions: physical comfort (5 items), emotional state (4 items), physical independence (2 items), psychological support (2 items), and pain (2 items). Each item is scored on a scale from 0 to 10. The total score ranges from 0 (extremely poor quality of recovery) to 150 (excellent quality of recovery). A higher total score indicates a better postoperative recovery experience from the patient's perspective.
Time frame: At 24 hours after surgery
Length of postoperative hospital stay
The duration of hospitalization in days, calculated from the day of surgery to the day of meeting discharge criteria (e.g., adequate pain control with oral analgesics, no air leak, afebrile, able to ambulate independently).
Time frame: From the day of surgery until the day of discharge, assessed up to 30 days.
Incidence of intraoperative conversion
The rate of conversion from non-intubated anesthesia to conventional intubated general anesthesia due to unacceptable surgical conditions (e.g., poor lung collapse, diaphragmatic movement) or patient safety concerns (e.g., hypoxemia, hypercapnia, hemodynamic instability).
Time frame: During the surgical procedure (from anesthesia induction until skin closure).
Plan to share: Yes — De-identified individual participant data (IPD) that underlie the results reported in the primary and secondary outcomes of this study will be shared. This includes demographic data, perioperative parameters, and all assessed outcome measures.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The IPD and supporting documents will become available 6 months after the publication of the primary study results (the main manuscript). The data will be accessible for a period of 5 years.
Access criteria: Researchers who provide a methodologically sound proposal for use in achieving the goals of the approved proposal may request access. Proposals should be directed to the corresponding author via email. Data requestors will need to sign a data access/use agreement. The shared data will be available for analyses aimed at replicating the study results, conducting secondary analyses, or performing meta-analyses.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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The First Affiliated Hospital of Guangzhou Medical University →