Clinical Trial

Tubeless Surgery With Impaired Pulmonary Function

Recruiting
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Record status
This record was last updated July 23, 2026 (before its estimated July 31, 2026 completion). Its status may not reflect the trial's current state.
Summary
Some patients with impaired lung function require minimally invasive surgical treatment, including those with lung cancer, benign lung tumors, pneumothorax, or lung volume reduction surgery. Patients with borderline lung function often cannot be extubated immediately postoperatively under conventional treatment models. These patients typically need to be transferred to the surgical ICU for close monitoring. However, positive-pressure mechanical ventilation with an endotracheal tube carries risks of further airway injury and persistent air leakage from the lung surface, leading to a high incidence of postoperative respiratory failure. Non-intubated minimally invasive surgery (tubeless), which preserves spontaneous breathing without endotracheal intubation, avoids the physical stimulation of intubation and the airway damage caused by mechanical ventilation. This approach may reduce the incidence of postoperative airway injury and respiratory failure, potentially expanding the indications for minimally invasive lung surgery, lowering postoperative complication and mortality rates. The aim is to further clarify the surgical indications for non-intubated single-port minimally invasive surgery in patients with impaired lung function, the decision-making criteria for postoperative ICU transfer, and the safety and feasibility of this comprehensive management approach.
Protocol Amendment History 2 changes
notable Enrollment increased: 30 -> 45 participants 2026-07-24
notable Primary completion pushed: 2025-12-31 -> 2026-07-31 2026-07-24
Trial Details
NCT Number NCT06848751
Lead Sponsor The Second Hospital of Shandong University
Conditions Lung Function Decreased, Surgery
Enrollment 45 participants
Start Date 2021-04-10
Primary Completion 2026-07-31 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-07-23