COPDNCT06922916
Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study
An observational study of COPD and Interstitial Pneumonia, run by Zhejiang University at 1 site in China.
Trial summary
This study analyzes patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University from 2017 to 2024, focusing on anesthesia's impact on post-op results. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD, Interstitial Pneumonia, Bronchiectasis
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2025to 30 Apr 2026
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University between January 2017 and October 2024
Who may be able to join
- Age >18 years at time of transplantation
- Received single or bilateral lung transplantation
Who cannot join
- Re-transplantation
- Multi-organ transplantation
- Autotransplantation
- Incomplete medical records: Recipients with >20% missing essential data elements in any of these categories:Preoperative baseline characteristics； Intraoperative parameters；Postoperative outcome measures
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
The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310000
Hangzhou, Zhejiang, 310000
About this study
This study analyzes patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University from 2017 to 2024, focusing on anesthesia's impact on post-op results. It gathers patient data from hospital and Mediston systems, with main focus on in-hospital complications and secondary focus on ICU stay, post-op hospitalization, mortality, and intubation time. The research aims to deepen understanding of anesthetic management's role in lung transplant outcomes and guide improvements in perioperative anesthesia protocols.
- Conditions
- COPD, Interstitial Pneumonia, Bronchiectasis, Respiratory Failure, Idiopathic Pulmonary Fibrosis (IPF), Silicosis
- Keywords
- lung transplantatipn, Perioperative-related risks, Mortality, In-hospital complications, Prognosis
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Lung Diseases, Interstitial, Bronchiectasis, Respiratory Insufficiency, Idiopathic Pulmonary Fibrosis, Silicosis, Tuberculosis, Pulmonary, Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lung transplantation group | In this group, we collected perioperative clinical data and analyzed risk factors associated with patient outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital adverse events
In-hospital adverse events were defined as post-transplant complications occurring prior to discharge, such as: Grade 3 PGD, respiratory infections, stroke, cardiac events, AKI, or liver impairment.
Measured: Collect data for an expected average about 2 hours
Secondary outcomes (6)
ICU stay
The ICU stay （days） was calculated from the time of ICU admission after surgery completion to actual discharge from the intensive care unit
Measured: Collect data for an expected average about 2 hours
Postoperative hospital stay
Postoperative hospital（days）stay after lung transplantation
Measured: Collect data for an expected average about 2 hours
In-hospital mortality
The proportion of patients who died during the initial hospitalization period following lung transplantation surgery
Measured: Collect data for an expected average about 2 hours
30-day postoperative mortality
Number of deaths within 30 days post-transplant) / (Total number of lung transplant recipients) × 100%；
Measured: Collect data for an expected average about 2 hours
90-day postoperative mortality
Number of deaths within 90 days post-transplant) / (Total number of lung transplant recipients) × 100%
Measured: Collect data for an expected average about 2 hours
The duration of endotracheal intubation
Duration of intubation should be recorded from surgery end-time to extubation
Measured: Collect data for an expected average about 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start22 Apr 2025 (estimated)
- Primary completion6 Apr 2026 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diansan Su, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922916
- Sponsor's protocol ID
- ZJU2025B0268
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 22 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Risk Factors Related to the Prognosis of Lung Transplantation: A Retrospective Study
- ClinicalTrials.gov ID
- NCT06922916
- Acronym / sponsor ID
- ZJU2025B0268
- Conditions
- COPD, Interstitial Pneumonia, Bronchiectasis, Respiratory Failure, Idiopathic Pulmonary Fibrosis (IPF), Silicosis
- Keywords
- lung transplantatipn, Perioperative-related risks, Mortality, In-hospital complications, Prognosis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 22 Apr 2025 (estimated)
- Primary completion
- 6 Apr 2026 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 11 Apr 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.
This study analyzes patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University from 2017 to 2024, focusing on anesthesia's impact on post-op results. It gathers patient data from hospital and Mediston systems, with main focus on in-hospital complications and secondary focus on ICU stay, post-op hospitalization, mortality, and intubation time. The research aims to deepen understanding of anesthetic management's role in lung transplant outcomes and guide improvements in perioperative anesthesia protocols.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung transplantation group | – | –In this group, we collected perioperative clinical data and analyzed risk factors associated with patient outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent lung transplantation at the First Affiliated Hospital of Zhejiang University between January 2017 and October 2024
Key inclusion criteria (2 listed)
- Age >18 years at time of transplantation
- Received single or bilateral lung transplantation
Key exclusion criteria (4 listed)
- Re-transplantation
- Multi-organ transplantation
- Autotransplantation
- Incomplete medical records: Recipients with >20% missing essential data elements in any of these categories:Preoperative baseline characteristics； Intraoperative parameters；Postoperative outcome measures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-hospital adverse events
Time frame: Collect data for an expected average about 2 hours
In-hospital adverse events were defined as post-transplant complications occurring prior to discharge, such as: Grade 3 PGD, respiratory infections, stroke, cardiac events, AKI, or liver impairment.
6 secondary outcomes
ICU stay
Time frame: Collect data for an expected average about 2 hours
Postoperative hospital stay
Time frame: Collect data for an expected average about 2 hours
In-hospital mortality
Time frame: Collect data for an expected average about 2 hours
30-day postoperative mortality
Time frame: Collect data for an expected average about 2 hours
90-day postoperative mortality
Time frame: Collect data for an expected average about 2 hours
The duration of endotracheal intubation
Time frame: Collect data for an expected average about 2 hours
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 22 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD and Interstitial Pneumonia, run by Zhejiang 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 2 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: opening soon, as of the sponsor's last update on 22 Apr 2025. 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 Diansan Su, Dr (+8618616514088, diansansu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital adverse events (time frame: Collect data for an expected average about 2 hours). 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 22 Apr 2025.