Tubeless Strategy for Enhanced Recovery After Sublobar Resection

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

Tubeless Strategy Within an Enhanced Recovery After Surgery (ERAS) Protocol for Thoracoscopic Sublobar Resection: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

138

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

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:

  • 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 informed consent.
  • American Society of Anesthesiologists (ASA) physical status I-III.

Exclusion Criteria:

  • Severe pleural adhesions or fibrosis that would preclude non-intubated anesthesia or tubeless approach.
  • Severe cardiopulmonary dysfunction: FEV1 < 50% predicted, DLCO < 60% predicted, heart failure (NYHA 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.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Airway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery.
Drug: Thoracic Paravertebral Block with Local Anesthetic
Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.
Procedure: Non-intubated Anesthesia
General anesthesia with spontaneous ventilation without endotracheal intubation.
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
Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia.
Device: Chest Tube Drainage
Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
24-hour high-quality recovery rate
Time Frame: 24 hours after surgery
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.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative complications (Clavien-Dindo classification)
Time Frame: From surgery until 30 days after discharge
Incidence and severity of postoperative complications classified according to the Clavien-Dindo classification, including pneumothorax, atelectasis, and pleural effusion requiring intervention.
From surgery until 30 days after discharge

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)

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

January 24, 2026

First Submitted That Met QC Criteria

February 6, 2026

First Posted (Actual)

February 13, 2026

Study Record Updates

Last Update Posted (Actual)

February 13, 2026

Last Update Submitted That Met QC Criteria

February 6, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TL-ERAS-SLR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

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.

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