Tubeless Strategy for Enhanced Recovery After Sublobar Resection

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Laryngeal Mask Airway
  Airway management using a laryngeal mask airway with spontaneous ventilation during thoracoscopic surgery.
• Препарат Thoracic Paravertebral Block with Local Anesthetic
  Thoracic paravertebral block using local anesthetic (e.g., ropivacaine) for intraoperative and postoperative analgesia.
• Процедура Non-intubated Anesthesia
  General anesthesia with spontaneous ventilation without endotracheal intubation.
• Устройство Double-lumen Endotracheal Tube
  Double-lumen endotracheal intubation for one-lung ventilation under general anesthesia.
• Устройство Chest Tube Drainage
  Routine placement of a chest tube (18-22 Fr) with water-seal drainage postoperatively.

Первичные конечные точки

• 24-hour high-quality recovery rate [Срок оценки: 24 hours after surgery]

Вторичные конечные точки (1)

• Postoperative complications (Clavien-Dindo classification) [Срок оценки: From surgery until 30 days after discharge]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• The First Affiliated Hospital of GZMU — Гуанчжоу

Публикации

• 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
• 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
• 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
• 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
• 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/ezy3 PMID 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. PMID 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. PMID 7891489

Идентификаторы

NCT: NCT07409129 · TL-ERAS-SLR

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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