Tubeless Strategy for Enhanced Recovery After Sublobar Resection

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe First Affiliated Hospital of Guangzhou Medical University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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/Surgery

    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.

Treatment groups

138 Participants
are divided into 2 treatment groups
Group A: Tubeless Strategy GroupExperimental treatment 3 interventions
Group B: Traditional Strategy GroupActive comparator 2 interventions

Trial outcomes

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.

Time frame
24 hours after surgery

Secondary outcomes

1

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.

Time frame
From surgery until 30 days after discharge

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: