Actively Recruiting

Phase Not Applicable
Age: 14Years - 85Years
All Genders
NCT06848751

Tubeless Surgery With Impaired Pulmonary Function

Led by The Second Hospital of Shandong University · Updated on 2025-02-27

30

Participants Needed

1

Research Sites

298 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Tubeless Surgery With Impaired Pulmonary Function

Who Can Participate

Age: 14Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with impaired lung function who may require postoperative intubation and surgical ICU transfer after preoperative and multidisciplinary team discussions
  • Patients needing minimally invasive lung resection for lung cancer, pulmonary nodules, benign lung tumors, pneumothorax, or lung volume reduction surgery
  • Patients with normal mental status able to cooperate with perioperative examinations, exercises, and physical rehabilitation
  • Patients who agree to participate in the clinical trial after communication
Not Eligible

You will not qualify if you...

  • Patients with severe impairment of cardiopulmonary function or other organ systems unable to tolerate anesthesia or minimally invasive surgery after preoperative and multidisciplinary team discussions
  • Patients with abnormal mental status or unable to cooperate with perioperative examinations, exercises, and physical rehabilitation
  • Patients who refuse to participate in the trial or decline non-intubated anesthesia with preserved spontaneous breathing
  • Patients who refuse to undergo surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Hospital of Shandong University

Jinan, Shandong, China, 250033

Actively Recruiting

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Research Team

Y

Yunpeng Zhao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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