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RecruitingNCT06848751Updated Jul 23, 2026

Tubeless Surgery With Impaired Pulmonary Function

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

From the registry’s dates

  • Primary completion was expected by Jul 2026, 3 months ago, but the record still lists the study as recruiting.
  • Registered 3 years 10 months after the study started (first participant enrolled Apr 2021, registered Feb 2025).
  • Started Apr 2021; still recruiting 5 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
14 Years to 85 Years
Sex
All
01

Study 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.

Read the detailed description

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.

02

Conditions studied

  • Lung Function Decreased
  • Surgery
03

In context

Respiratory Insufficiency

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.

Browse Respiratory Insufficiency studies →

Lead sponsor

The Second Hospital of Shandong University is the lead sponsor of 35 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Patients with abnormal mental status or who are unable to adequately cooperate with perioperative examinations, exercises, and physical rehabilitation measures.
  3. Patients who refuse to participate in the clinical trial or decline the use of non-intubated anesthesia with preserved spontaneous breathing.
  4. Patients who refuse to undergo surgery.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    tubeless group

    Non-intubated thoracoscopic surgery for lung leisions in patients with impaired pulmonary function

    Procedure: Non-intubated thoracoscopic surgery

Interventions

  • ProcedureNon-intubated thoracoscopic surgery

    Non-intubated thoracoscopic lung surgery for patients with impaired pulmonary function

06

What researchers measure

Primary outcomes

  1. complication rate

    complication rate after surgery

    Time frame: within 30 days after surgery

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06848751
Lead sponsor
The Second Hospital of Shandong University
Responsible party
Sponsor
First posted
Feb 27, 2025
Start date
Apr 10, 2021
Primary completion
Jul 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 23, 2026

Study contacts

Yunpeng Zhao
Contact
zhaoyunpengsddx@sdu.edu.cn
18766188692
Yunpeng Zhao
principal investigator · The Second Hospital of Shandong University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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