Tubeless Surgery With Impaired Pulmonary Function

Recruiting now · Not applicable

Conditions studied: Lung Function Decreased, Surgery

In brief

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.

Key facts

Study ID

NCT06848751

Run by

The Second Hospital of Shandong University

People needed

45

Starts

2021-04-10

Expected to finish

2026-12-31

Last updated by the study team

2026-07-23

Who can join

Age: 14 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with impaired lung function (who may require postoperative intubation and transfer to the surgical ICU after preoperative and MDT discussions).
• Patients requiring minimally invasive lung resection due to lung cancer, pulmonary nodules, benign lung tumors, pneumothorax, lung volume reduction surgery, etc.
• Patients with normal mental status who can cooperate with perioperative examinations, exercises, and physical rehabilitation measures.
• Patients who agree to participate in the clinical trial after communication.

You may not qualify if…

• Patients with severe impairment of cardiopulmonary function or other organ systems, who are deemed unable to tolerate any form of anesthesia or minimally invasive surgery after preoperative and MDT discussions.
• Patients with abnormal mental status or who are unable to adequately cooperate with perioperative examinations, exercises, and physical rehabilitation measures.
• Patients who refuse to participate in the clinical trial or decline the use of non-intubated anesthesia with preserved spontaneous breathing.
• Patients who refuse to undergo surgery.

Where it is running

• The Second Hospital of Shandong University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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