ClinicalTrials.gg
Not yet recruitingNCT07409129Updated Feb 13, 2026

Tubeless Strategy for Enhanced Recovery After Sublobar Resection

An interventional study of Laryngeal Mask Airway and Thoracic Paravertebral Block with Local Anesthetic in Pulmonary Nodules, Early Stage Lung Cancer (I and II) and Thoracoscopic 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 75 Years. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by The First Affiliated Hospital of Guangzhou Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
138
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a prospective, randomized controlled clinical trial conducted at a single center. The study aims to evaluate whether a "tubeless" strategy can enhance recovery for patients undergoing minimally invasive thoracoscopic sublobar resection (wedge or segment resection) for small lung nodules.

Participants will be randomly assigned to one of two groups:

  • The experimental group will receive the "tubeless" strategy, which includes non-endotracheal intubation anesthesia (using a laryngeal mask) and no routine chest tube drainage after surgery.
  • The control group will receive the traditional strategy, which includes double-lumen endotracheal intubation anesthesia and routine chest tube drainage.

The main goal is to compare the rate of achieving high-quality fast-track recovery at 24 hours after surgery between the two groups. This study will provide evidence on whether the tubeless approach can help patients recover faster and more comfortably without compromising safety.

Read the detailed description

This is a prospective, open-label, randomized controlled trial with a 1:1 allocation ratio. Adult patients (aged 18-75) scheduled for uniportal VATS sublobar resection for peripheral lung nodules (≤2 cm, ≤2 cm from the pleura) will be assessed for eligibility. Key exclusion criteria include severe pleural adhesions, inability to achieve selective lung ventilation, and severe cardiopulmonary dysfunction.

The primary outcome is a composite endpoint measuring the rate of high-quality fast-track recovery at 24 hours postoperatively, defined as simultaneously meeting all three criteria: 1) meeting standardized discharge criteria, 2) a QoR-15 (Quality of Recovery-15) score ≥130, and 3) absence of Clavien-Dindo grade ≥II respiratory adverse events until the first follow-up.

Secondary outcomes include individual components of the primary endpoint, pneumothorax rate, postoperative pain scores, time to first ambulation, length of hospital stay, hospitalization costs, and patient satisfaction. A sample size of 138 participants (69 per group) was calculated to provide sufficient statistical power. Data analysis will follow the intention-to-treat principle.

02

Conditions studied

  • Pulmonary Nodules
  • Early Stage Lung Cancer (I and II)
  • Thoracoscopic Surgery
  • Sublobar Resection

Keywords

  • Tubeless Surgery
  • Non-intubated Anesthesia
  • Enhanced Recovery After Surgery
  • Sublobar resection
  • Wedge Resection
  • Segmentectomy
03

In context

Multiple Pulmonary Nodules

99 studies on the registry are indexed under Multiple Pulmonary Nodules; 42 are open to participants now.

This study's planned enrollment of 138 is above the median of 97 across 46 interventional studies indexed under Multiple Pulmonary Nodules.

Browse Multiple Pulmonary Nodules studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Age between 18 and 75 years.
  • Scheduled for uniportal or multiportal video-assisted thoracoscopic surgery (VATS) for sublobar resection (wedge or segmentectomy).
  • Presence of peripheral lung nodules ≤ 2 cm in diameter and ≤ 2 cm from the pleura, confirmed by CT scan.
  • Ability to understand and provide written .
  • (ASA) physical status I-III.

Exclusion criteria

Exclusion Criteria:

  • Severe pleural adhesions or fibrosis that would preclude non-intubated anesthesia or tubeless approach.
  • Severe cardiopulmonary dysfunction: \< 50% predicted, DLCO \< 60% predicted, heart failure ( class III-IV), or unstable angina.
  • Pregnancy or lactation (confirmed by urine test if applicable).
  • Inability to tolerate one-lung ventilation due to anatomical or physiological reasons.
  • History of ipsilateral thoracic surgery.
  • Active pulmonary infection, uncontrolled diabetes, or other comorbidities that increase surgical risk.
  • Participation in another interventional trial within 30 days.
Terms in these criteria, in plain language(4)

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.

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.

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.

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.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

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.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
138 participants (estimated)

Study arms

  • Experimental
    Tubeless Strategy Group

    Participants in this arm receive the tubeless strategy: * Anesthesia: Laryngeal mask airway with spontaneous ventilation (non-intubated). * Drainage: No chest tube placement after surgery * Goal: To enhance recovery by minimizing invasive procedures.

    Device: Laryngeal Mask Airway · Drug: Thoracic Paravertebral Block with Local Anesthetic · Procedure: Non-intubated Anesthesia

  • Active comparator
    Traditional Strategy Group

    Participants in this arm receive the conventional standard care: * Anesthesia: Double-lumen endotracheal intubation with mechanical ventilation. * Drainage: Routine chest tube drainage with water-seal suction postoperatively. * Follows current clinical guidelines for thoracoscopic sublobar resection.

    Device: Double-lumen Endotracheal Tube · Device: Chest Tube Drainage

Interventions

  • DeviceLaryngeal Mask Airway

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

  • DrugThoracic Paravertebral Block with Local Anesthetic

    Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.

  • ProcedureNon-intubated Anesthesia

    General anesthesia with spontaneous ventilation without endotracheal intubation.

  • DeviceDouble-lumen Endotracheal Tube

    Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia.

  • DeviceChest Tube Drainage

    Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.

06

What researchers measure

Primary outcomes

  1. 24-hour high-quality recovery rate

    Composite endpoint defined as meeting all of the following criteria at 24 hours postoperatively: (1) meeting standardized discharge criteria (stable vital signs, controlled pain, autonomous ambulation); (2) Quality of Recovery-15 (QoR-15) score ≥130 (range 0-150; higher scores indicate better recovery); and (3) absence of Clavien-Dindo grade ≥II respiratory complications.

    Time frame: 24 hours after surgery

Secondary outcomes

  1. Postoperative complications (Clavien-Dindo classification)

    Incidence and severity of postoperative complications classified according to the Clavien-Dindo classification, including pneumothorax, atelectasis, and pleural effusion requiring intervention.

    Time frame: From surgery until 30 days after discharge

07

Study locations

1 site
08

References and documents

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 ↗
  • Chen JS, Cheng YJ, Hung MH, Tseng YD, Chen KC, Lee YC. Nonintubated thoracoscopic lobectomy for lung cancer. Ann Surg. 2011 Dec;254(6):1038-43. doi: 10.1097/SLA.0b013e31822ed19b. PubMed 21869676 ↗
  • Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301. PubMed 30304509 ↗
  • Khoury AL, McGinigle KL, Freeman NL, El-Zaatari H, Feltner C, Long JM; University of North Carolina School of Medicine Enhanced Recovery Program Working Group. Enhanced recovery after thoracic surgery: Systematic review and meta-analysis. JTCVS Open. 2021 Jul 15;7:370-391. doi: 10.1016/j.xjon.2021.07.007. eCollection 2021 Sep. PubMed 36003715 ↗
  • Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6. PubMed 7891489 ↗

Individual participant data

Plan to share: Yes — The de-identified individual participant data that underlie the results reported in the primary publication of this trial will be shared. This includes baseline characteristics (age, gender, BMI), intraoperative data (operation time, blood loss), and primary and secondary outcome data (e.g., QoR-15 scores, pneumothorax rates, length of stay, complication rates).

Supporting information: Study protocol, Statistical analysis plan, Informed consent form

Time frame: The IPD and supporting documents will become available within 6 months after the publication of the primary trial results. The data will be accessible for a minimum of 5 years.

Access criteria: The IPD will be accessible to researchers who provide a methodologically sound research proposal approved by an independent review committee. Proposals should be directed to the corresponding author. Data will be shared for the purpose of achieving the approved research aims. A data access agreement must be signed before data release.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Feb 2026; primary completion for Jun 2026, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 24, 2026
First posted
Feb 13, 2026
StartEst.
Feb 1, 2026
Primary completionEst.
Jun 1, 2026
CompletionEst.
Sep 1, 2026
Last update
Feb 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07409129
Responsible party
Jianxing He (Professor of Thoracic Surgery, The First Affiliated Hospital of Guangzhou Medical University) — Principal investigator
First posted
Feb 13, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Jun 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Feb 13, 2026

Study contacts

Jianxing He, Ph.D
Contact
drjianxing.he@gmail.com
86+020-83062807

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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