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Lung Function DecreasedNCT06848751

Tubeless Surgery With Impaired Pulmonary Function

A study testing Non-intubated thoracoscopic surgery in people with Lung Function Decreased and Surgery, run by The Second Hospital of Shandong University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 14 to 85 years
Conditions the study is for
Lung Function Decreased, Surgery
What is being tested?
Non-intubated thoracoscopic surgery
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteChina
Study dates
10 Apr 2021to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 85 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • The Second Hospital of Shandong University

    Jinan, Shandong, 250033

    Yunpeng Zhao, +8618766188692, zhaoyunpengsddx@sdu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Non-intubated Thoracoscopic Surgery for Lung Leision in Patients With Impaired Pulmonary Function

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.

Being tested
Non-intubated thoracoscopic surgery
Medical subject headings
Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-intubated thoracoscopic surgeryProcedure or surgery

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

Study groups in NCT06848751
Study groupRoleWhat they receive
tubeless groupExperimentalNon-intubated thoracoscopic surgery for lung leisions in patients with impaired pulmonary function
Receives: Procedure: Non-intubated thoracoscopic surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complication rate

    complication rate after surgery

    Measured: within 30 days after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Feb 2025
  2. Study start10 Apr 2021
  3. Primary completion31 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06848751
Sponsor's protocol ID
TRIP-ZYP
Status last verified
Jul 2026
First submitted
22 Feb 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Non-intubated thoracoscopic surgery in people with Lung Function Decreased and Surgery, run by The Second Hospital of Shandong University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yunpeng Zhao (18766188692, zhaoyunpengsddx@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complication rate (time frame: within 30 days after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.

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