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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 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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tubeless Strategy Group | Experimental | Participants in this arm receive the tubeless strategy:
|
|
| Traditional Strategy Group | Active Comparator | Participants in this arm receive the conventional standard care:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laryngeal Mask Airway | Device | Airway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From surgery until 30 days after discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianxing He, Ph.D | Contact | 86+020-83062807 | drjianxing.he@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of GZMU | Guangzhou | China | 510120 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31725158 | Result | 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. | |
| 35430086 | 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. |
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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).
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.
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.
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This is a prospective, randomized, open-label, parallel-group, single-center trial with a 1:1 allocation ratio.
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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.
| Thoracic Paravertebral Block with Local Anesthetic | Drug | Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia. |
|
| Non-intubated Anesthesia | Procedure | General anesthesia with spontaneous ventilation without endotracheal intubation. |
|
| Double-lumen Endotracheal Tube | Device | Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia. |
|
| Chest Tube Drainage | Device | Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively. |
|
| 33785209 | 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. |
| 21869676 | 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. |
| 30304509 | 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. |
| 36003715 | 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. |
| 7891489 | 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. |
| ID | Term |
|---|---|
| D055613 | Multiple Pulmonary Nodules |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017214 | Laryngeal Masks |
| D000779 | Anesthetics, Local |
| ID | Term |
|---|---|
| D007442 | Intubation, Intratracheal |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D007440 | Intubation |
| D008919 | Investigative Techniques |
| D008397 | Masks |
| D011482 | Protective Devices |
| D004864 | Equipment and Supplies |
| D000067393 | Personal Protective Equipment |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
| D000777 | Anesthetics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
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