Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection
NIVA-TSLR
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
1 other identifier
interventional
1,600
1 country
1
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2026
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2026
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedStudy Start
First participant enrolled
March 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
February 9, 2026
January 1, 2026
1.3 years
January 24, 2026
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
At 24 hours after surgery
Secondary Outcomes (2)
Length of postoperative hospital stay
From the day of surgery until the day of discharge, assessed up to 30 days.
Incidence of intraoperative conversion
During the surgical procedure (from anesthesia induction until skin closure).
Study Arms (2)
Non-intubated Anesthesia Group
EXPERIMENTALPatients 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.
Conventional Anesthesia Group
ACTIVE COMPARATORPatients 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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).
- 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.
- Contraindications to Regional Anesthesia: Infection/tumor at the block site, patient refusal, or allergy to local anesthetics.
- Coagulopathy: Platelet count \< 100×10⁹/L, INR \> 1.5, or use of anticoagulants that cannot be safely discontinued perioperatively.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The First Affiliated Hospital of GZMU
Guangzhou, China
Related Publications (4)
Wen Y, Liang H, Qiu G, Liu Z, Liu J, Ying W, Liang W, He J. Non-intubated spontaneous ventilation in video-assisted thoracoscopic surgery: a meta-analysis. Eur J Cardiothorac Surg. 2020 Mar 1;57(3):428-437. doi: 10.1093/ejcts/ezz279.
PMID: 31725158RESULTMyles PS, Shulman MA, Reilly J, Kasza J, Romero L. Measurement of quality of recovery after surgery using the 15-item quality of recovery scale: a systematic review and meta-analysis. Br J Anaesth. 2022 Jun;128(6):1029-1039. doi: 10.1016/j.bja.2022.03.009. Epub 2022 Apr 14.
PMID: 35430086RESULTLiu J, Liang H, Cui F, Liu H, Zhu C, Liang W, He J; International Tubeless-Video-Assisted Thoracoscopic Surgery Collaboration. Spontaneous versus mechanical ventilation during video-assisted thoracoscopic surgery for spontaneous pneumothorax: A randomized trial. J Thorac Cardiovasc Surg. 2022 May;163(5):1702-1714.e7. doi: 10.1016/j.jtcvs.2021.01.093. Epub 2021 Feb 3.
PMID: 33785209RESULTZhang Z, Feng H, Zhao H, Hu J, Liu L, Liu Y, Li X, Xu L, Li Y, Lu X, Fu X, Yang H, Liu D. Sublobar resection is associated with better perioperative outcomes in elderly patients with clinical stage I non-small cell lung cancer: a multicenter retrospective cohort study. J Thorac Dis. 2019 May;11(5):1838-1848. doi: 10.21037/jtd.2019.05.20.
PMID: 31285876RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Chief of Thoracic Surgery Department
Study Record Dates
First Submitted
January 24, 2026
First Posted
February 9, 2026
Study Start
March 1, 2026
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
February 9, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
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.