An interventional study of Non-intubated thoracoscopic surgery in Lung Function Decreased and Surgery, sponsored by The Second Hospital of Shandong University. Recruiting at 1 site in China. Open to participants aged 14 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-07-23.
Sponsored by The Second Hospital of Shandong University · Not applicable, Interventional, and Treatment
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.
Research Background 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. After a thorough preoperative cardiopulmonary function assessment and multidisciplinary team (MDT) discussions, 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. Throughout the procedure, patients maintain spontaneous breathing, and most can avoid ICU transfer postoperatively. Some patients may even be able to get out of bed on the same day of surgery. 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, shortening hospital stays, and reducing costs and healthcare expenditures. It represents a new quality productivity in minimally invasive surgery.
Research Objectives 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.
Research Methods
Literature Review: First, we will conduct a review of relevant medical literature to understand existing research outcomes and methodologies. This will provide a foundation and reference for our study.
Study Design: Based on the literature review, we will design a clinical trial for validation and exploration. This study is a prospective observational study aimed at confirming safety and feasibility while conducting exploratory analyses.
Data Analysis: Data obtained from the study will undergo statistical analysis and visualization to better interpret the experimental results. Appropriate statistical methods and software tools will be used to ensure data reliability and interpretability.
Expected Outcomes Through this study, we expect to define the surgical indications (lung function evaluation criteria and lung function improvement protocols) for non-intubated single-port minimally invasive lung resection in patients with impaired lung function. We aim to identify high-risk factors for postoperative ICU transfer and poor prognosis in these patients, thereby proposing a new safe protocol for minimally invasive surgery in this population. We hope to demonstrate the safety and efficacy of this approach, contributing to advancements in the medical field.
Research Significance The significance of this study lies in providing a new medical intervention protocol, offering a safe and effective comprehensive solution (including preoperative assessment, preoperative preparation, anesthesia and surgical interventions, and postoperative management) for minimally invasive lung resection in patients with impaired lung function. It addresses the current high-risk status of these patients undergoing surgery, potentially improving outcomes and reducing complications.
1,369 studies on the registry are indexed under Respiratory Insufficiency; 264 are open to participants now.
This study's planned enrollment of 45 is below the median of 60 across 860 interventional studies indexed under Respiratory Insufficiency.
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Exclusion Criteria:
Non-intubated thoracoscopic surgery for lung leisions in patients with impaired pulmonary function
Procedure: Non-intubated thoracoscopic surgery
Non-intubated thoracoscopic lung surgery for patients with impaired pulmonary function
complication rate
complication rate after surgery
Time frame: within 30 days after surgery
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The Second Hospital of Shandong University