Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection (NIVA-TSLR)

February 6, 2026 updated by: Jianxing He, The First Affiliated Hospital of Guangzhou Medical University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Guangzhou, China
        • The First Affiliated Hospital of GZMU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Aged 18 to 80 years (inclusive).
  2. Scheduled for elective, uniportal or single utility port video-assisted thoracoscopic sublobar resection (wedge resection or simple anatomical segmentectomy).
  3. Preoperative CT diagnosis of a peripheral pulmonary nodule meeting: maximum diameter ≤ 2.0 cm and outer edge ≤ 2.0 cm from the visceral pleura.
  4. American Society of Anesthesiologists (ASA) physical status I or II.
  5. Preoperative pulmonary function: FEV1% ≥ 60% of predicted.
  6. Preoperative arterial blood gas analysis (room air): PaO₂ ≥ 80 mmHg and PaCO₂ ≤ 45 mmHg.
  7. Body Mass Index (BMI) between 18.0 and 28.0 kg/m².
  8. Able to understand the study and provide written informed consent.

Exclusion Criteria:

  1. Cardiovascular: NYHA class ≥ III, unstable angina, acute myocardial infarction within 3 months, or severe arrhythmia requiring medication.
  2. 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).
  3. Airway Risk: Modified Mallampati score ≥ 3, mouth opening < 3 cm, or other predictors of difficult airway management.
  4. Radiological: Preoperative CT suggesting extensive pleural adhesion, moderate or large pleural effusion, or mediastinal lymph nodes > 1.5 cm short axis.
  5. Contraindications to Regional Anesthesia: Infection/tumor at the block site, patient refusal, or allergy to local anesthetics.
  6. Coagulopathy: Platelet count < 100×10⁹/L, INR > 1.5, or use of anticoagulants that cannot be safely discontinued perioperatively.
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-intubated Anesthesia Group

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
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.
Device: Laryngeal Mask Airway (LMA)
Airway management using a laryngeal mask airway to maintain spontaneous ventilation during thoracoscopic surgery.
Drug: Intravenous Sedation/Anesthesia (Spontaneous Ventilation)
Intravenous sedative/anesthetic agents administered to achieve adequate anesthesia while preserving spontaneous breathing.
Drug: Regional Nerve Block (Paravertebral/Intercostal Block)
Regional anesthesia with local anesthetic (e.g., paravertebral or intercostal block) for perioperative analgesia.
Active Comparator: Conventional Anesthesia Group

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
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.
Device: Double-lumen Endotracheal Tube (DLT)
Double-lumen endotracheal tube used to achieve one-lung ventilation during general anesthesia.
Drug: General Anesthesia With Neuromuscular Blockade
General anesthesia maintained with intravenous and/or inhalational agents with muscle relaxation for controlled mechanical ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of composite perioperative complications
Time Frame: From anesthesia induction up to 30 days after surgery
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.
From anesthesia induction up to 30 days after surgery
Postoperative recovery quality assessed by the QoR-15 score
Time Frame: At 24 hours after surgery
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.
At 24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of postoperative hospital stay
Time Frame: From the day of surgery until the day of discharge, assessed up to 30 days.
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).
From the day of surgery until the day of discharge, assessed up to 30 days.
Incidence of intraoperative conversion
Time Frame: During the surgical procedure (from anesthesia induction until skin closure).
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).
During the surgical procedure (from anesthesia induction until skin closure).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

January 24, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIT-Sublobar-VATS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Neoplasms

Clinical Trials on Non-intubated Anesthesia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe