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NCT Number: NCT07409129

Tubeless Strategy for Enhanced Recovery After Sublobar Resection

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Laryngeal mask airway

Device

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

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jianxing He, Ph.D

CONTACT

[email protected]

86+020-83062807

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Guangzhou Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 13, 2026
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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