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.
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
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Yunpeng Zhao, +8618766188692, zhaoyunpengsddx@sdu.edu.cn
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.
- Conditions
- Lung Function Decreased, Surgery
- 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 group | Role | What they receive |
|---|---|---|
| tubeless group | Experimental | Non-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.
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.
- First posted27 Feb 2025
- Study start10 Apr 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Function DecreasedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- The Second Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yunpeng Zhao, Principal investigator, The Second Hospital of Shandong University
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-intubated Thoracoscopic Surgery for Lung Leision in Patients With Impaired Pulmonary Function
- ClinicalTrials.gov ID
- NCT06848751
- Acronym / sponsor ID
- TRIP-ZYP
- Conditions
- Lung Function Decreased, Surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- The Second Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| tubeless group | Experimental | Procedure: Non-intubated thoracoscopic surgeryNon-intubated thoracoscopic surgery for lung leisions in patients with impaired pulmonary function |
Who may qualify
- Ages
- 14 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-intubated thoracoscopic surgeryNon-intubated thoracoscopic lung surgery for patients with impaired pulmonary function | Procedure or surgery | tubeless group |
Primary outcome
complication rate
Time frame: within 30 days after surgery
complication rate after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yunpeng Zhao principal investigator
The Second Hospital of Shandong University
1 site in 1 country: see every site and its status.
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.