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Pulmonary NodulesNIVA-TSLRNCT07395375

Non-intubated Versus Intubated Anesthesia for Thoracoscopic Sublobar Resection

A study testing Non-intubated Anesthesia, Conventional Intubated General Anesthesia and Laryngeal Mask Airway (LMA) in people with Pulmonary Nodules and Lung Neoplasms, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Non-intubated Anesthesia, Conventional Intubated General Anesthesia and Laryngeal Mask Airway (LMA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,600 participants
Where
1 siteChina
Study dates
1 Mar 2026to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hengrui Liang, M.D. contact

+862083062114

liang_hengrui@163.com

China1 site
  • The First Affiliated Hospital of GZMU

    Guangzhou

    hengrui liang, 86+020-83062807, liang_hengrui@163.com

Other trials in China

About this study

Official title: 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).

Read more

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.

Being tested
Non-intubated Anesthesia, Conventional Intubated General Anesthesia, Laryngeal Mask Airway (LMA), Intravenous Sedation/Anesthesia (Spontaneous Ventilation), Regional Nerve Block (Paravertebral/Intercostal Block)
Keywords
Non-intubated Thoracic Surgery, Lung Sublobar Resection, Video-Assisted Thoracoscopic Surgery, Enhanced Recovery After Surgery, Randomized Controlled Trial
Medical subject headings
Multiple Pulmonary Nodules, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-intubated AnesthesiaProcedure or surgery

    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.

  • Conventional Intubated General AnesthesiaProcedure or surgery

    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.

  • Laryngeal Mask Airway (LMA)Device

    Airway management using a laryngeal mask airway to maintain spontaneous ventilation during thoracoscopic surgery.

  • Intravenous Sedation/Anesthesia (Spontaneous Ventilation)Drug

    Intravenous sedative/anesthetic agents administered to achieve adequate anesthesia while preserving spontaneous breathing.

  • Regional Nerve Block (Paravertebral/Intercostal Block)Drug

    Regional anesthesia with local anesthetic (e.g., paravertebral or intercostal block) for perioperative analgesia.

  • Double-lumen Endotracheal Tube (DLT)Device

    Double-lumen endotracheal tube used to achieve one-lung ventilation during general anesthesia.

  • General Anesthesia With Neuromuscular BlockadeDrug

    General anesthesia maintained with intravenous and/or inhalational agents with muscle relaxation for controlled mechanical ventilation.

Study groups in NCT07395375
Study groupRoleWhat they receive
Non-intubated Anesthesia GroupExperimentalPatients 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.
Receives: Procedure: Non-intubated Anesthesia; Device: Laryngeal Mask Airway (LMA); Drug: Intravenous Sedation/Anesthesia (Spontaneous Ventilation); Drug: Regional Nerve Block (Paravertebral/Intercostal Block)
Conventional Anesthesia GroupActive 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.
Receives: Procedure: Conventional Intubated General Anesthesia; Device: Double-lumen Endotracheal Tube (DLT); Drug: General Anesthesia With Neuromuscular Blockade

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From anesthesia induction up to 30 days after surgery

  2. 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.

    Measured: At 24 hours after surgery

Secondary outcomes (2)
  1. 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).

    Measured: From the day of surgery until the day of discharge, assessed up to 30 days.

  2. 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).

    Measured: During the surgical procedure (from anesthesia induction until skin closure).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Feb 2026
  2. Study start1 Mar 2026 (estimated)
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07395375
Sponsor's protocol ID
NIT-Sublobar-VATS
Acronym
NIVA-TSLR
Status last verified
Jan 2026
First submitted
24 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • 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.

    PubMed 31725158
  • Myles 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.

    PubMed 35430086
  • Liu 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.

    PubMed 33785209
  • Zhang 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.

    PubMed 31285876

Questions about this trial

What is this clinical trial studying?

A study testing Non-intubated Anesthesia, Conventional Intubated General Anesthesia and Laryngeal Mask Airway (LMA) in people with Pulmonary Nodules and Lung Neoplasms, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hengrui Liang, M.D. (+862083062114, liang_hengrui@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of composite perioperative complications (time frame: From anesthesia induction up to 30 days after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07395375, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.

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