Clinical trial · Interventional
Tubeless Strategy for Enhanced Recovery After Sublobar Resection
Tubeless Strategy Within an Enhanced Recovery After Surgery (ERAS) Protocol for Thoracoscopic Sublobar Resection: A Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Lung Cancer (I and II) | — | UNRESOLVED | — |
| Pulmonary Nodules | — | UNRESOLVED | — |
| Sublobar Resection | — | UNRESOLVED | — |
| Thoracoscopic Surgery | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chest Tube Drainage | Device | — | UNRESOLVED |
| Double-lumen Endotracheal Tube | Device | — | UNRESOLVED |
| Laryngeal Mask Airway | Device | — | UNRESOLVED |
| Non-intubated Anesthesia | Procedure | — | UNRESOLVED |
| Thoracic Paravertebral Block with Local Anesthetic | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tubeless Strategy Group
- description
- 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.
- interventionNames
- Device: Laryngeal Mask Airway
- Drug: Thoracic Paravertebral Block with Local Anesthetic
- Procedure: Non-intubated Anesthesia
- type
- ACTIVE_COMPARATOR
- label
- Traditional Strategy Group
- description
- 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.
- interventionNames
- Device: Double-lumen Endotracheal Tube
- Device: Chest Tube Drainage
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (7)
- RESULTWen 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
- RESULTMyles 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
- RESULTLiu 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
- RESULTChen 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
- RESULTBatchelor 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
- RESULTKhoury 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