NCT07120230

Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Study

Evaluation of the Safety and Rapid Recovery Effect of the Tubeless Strategy in Lung Transplantation: A Prospective Single-Arm Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The First Affiliated Hospital of Guangzhou Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This prospective, single-center, single-arm study evaluates the feasibility, safety, and rapid recovery outcomes of a tubeless strategy in lung transplantation. Consecutive eligible adult lung transplant recipients undergo lung transplantation without standard endotracheal intubation, using a laryngeal mask airway and standardized regional anesthesia and intravenous sedation protocols. The primary outcome is freedom from invasive ventilation in the operating room, defined as removal of the airway device before leaving the operating room with no reinstitution of invasive ventilation within 72 hours. Secondary outcomes include postoperative ICU length of stay, postoperative hospital length of stay, postoperative invasive ventilation requirement, postoperative complications (assessed up to 30 days), and perioperative mortality.

Detailed description

The study was initially registered as a randomized controlled trial. However, randomization was not feasible due to patient refusal of treatment allocation. Therefore, the study proceeded as a prospective single-arm cohort with consecutive enrollment. Outcome definitions remained unchanged. The study was conducted at a single center.

Conditions

• Lung Transplant Recipient

Interventions

Type	Name	Description
PROCEDURE	Tubeless Lung Transplantation Surgery	Patients undergoing this surgery receive lung transplantation surgery without standard tracheal intubation. Instead, they will breathe on their own using a special airway device called a laryngeal mask airway (LMA), combined with a bronchial blocker to separate lung ventilation during surgery. Sedation is maintained with intravenous medications (propofol, remifentanil, and dexmedetomidine), and participants will remain spontaneously breathing or receive minimal breathing assistance as needed. The surgical incision will be numbed using local anesthesia with lidocaine and ropivacaine injections. After surgery, the LMA will be removed in the operating room, and participants will transition directly to non-invasive breathing support before being monitored in the ICU.

Timeline

• Start date: 2025-08-03
• Primary completion: 2025-12-30
• Completion: 2026-01-30
• First posted: 2025-08-13
• Last updated: 2026-02-25

Locations

1 site across 1 country: China