Actively Recruiting

Phase Not Applicable
Age: 14Years - 85Years
All Genders
ID06848751

Non-intubated Thoracoscopic Surgery for Lung Lesions in Patients With Impaired Pulmonary Function

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

30

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Some patients with impaired lung function need minimally invasive surgery for conditions like lung cancer, benign lung tumors, pneumothorax, or lung volume reduction. Often, those with borderline lung function cannot be immediately taken off breathing support after surgery under traditional care and require close monitoring in the surgical ICU. However, using a breathing tube and mechanical ventilation in these cases can cause airway injury and prolonged air leaks, increasing the risk of respiratory failure after surgery. This research studies a non-intubated thoracoscopic surgery approach, which allows patients to keep breathing on their own without a breathing tube. This method avoids airway damage caused by intubation and mechanical ventilation and may reduce complications and ICU transfers. The study focuses on patients undergoing single-port, minimally invasive lung surgery with impaired lung function, aiming to clarify when this tubeless technique is suitable, how to decide on ICU transfer, and evaluate the safety and feasibility of this comprehensive management. Participants will be observed during their surgical treatment and recovery. Researchers will assess outcomes like complication rates within 30 days after surgery. The study includes preoperative assessments, multidisciplinary discussions, and postoperative monitoring to identify risks and improve protocols. Data analysis will help define lung function criteria and protocols to expand safe use of non-intubated surgery, potentially improving recovery, lowering complications, and reducing hospital stays and costs.

CONDITIONS

Brief 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 ICU transfer after preoperative and MDT 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 exams, exercises, and rehabilitation
  • Patients who agree to participate in the clinical trial after communication
Not Eligible

You will not qualify if you...

  • Patients with severe cardiopulmonary or other organ dysfunction unable to tolerate anesthesia or minimally invasive surgery after preoperative and MDT discussions
  • Patients with abnormal mental status or unable to cooperate with perioperative exams, exercises, and rehabilitation
  • Patients who refuse to participate in the clinical trial or decline non-intubated anesthesia with 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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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

screening and enrollment visit

Surgery and Immediate Post-operative Care

Duration - Day of surgery

Participants undergo non-intubated thoracoscopic lung surgery while maintaining spontaneous breathing, followed by immediate postoperative care without endotracheal intubation.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - Within 30 days after surgery

Participants are monitored for complications and recovery during the 30 days after surgery.

Approximately 6 post-operative visits

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

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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