Tubeless Strategy for Enhanced Recovery After Sublobar Resection

NCT07409129 | Not Yet Recruiting DMC

• 1 other identifier: TL-ERAS-SLR
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

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.

  24 hours after surgery

Secondary Outcomes (1)

• Postoperative complications (Clavien-Dindo classification)

  From surgery until 30 days after discharge

Study Arms (2)

Tubeless Strategy Group

EXPERIMENTAL

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

Traditional Strategy Group

ACTIVE COMPARATOR

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

Laryngeal Mask Airway DEVICE

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

Tubeless Strategy Group

Thoracic Paravertebral Block with Local Anesthetic DRUG

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

Tubeless Strategy Group

Non-intubated Anesthesia PROCEDURE

General anesthesia with spontaneous ventilation without endotracheal intubation.

Tubeless Strategy Group

Double-lumen Endotracheal Tube DEVICE

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

Traditional Strategy Group

Chest Tube Drainage DEVICE

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

Traditional Strategy Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of GZMU

Guangzhou, China, 510120, China

Location

Related Publications (7)

• 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: 31725158 RESULT

• 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.

  PMID: 35430086 RESULT

• 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.

  PMID: 33785209 RESULT

• 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.

  PMID: 21869676 RESULT

• 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.

  PMID: 30304509 RESULT

• 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.

  PMID: 36003715 RESULT

• 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.

  PMID: 7891489 RESULT

MeSH Terms

Conditions

Multiple Pulmonary Nodules

Interventions

Laryngeal Masks; Anesthetics, Local

Condition Hierarchy (Ancestors)

Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses

Central Study Contacts

Jianxing He, Ph.D

CONTACT

86+020-83062807; drjianxing.he@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the interventions (anesthesia and drainage strategies), blinding of the participants or the care providers is not feasible. However, the outcome assessors will be blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Thoracic Surgery

Model Details: This is a prospective, randomized, open-label, parallel-group, single-center trial with a 1:1 allocation ratio.

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.

Locations

CN (1)