Lung TransplantationNCT06218758
Prediction Model for PPCs in Patients Undergoing Lung Transplantation Using Machine Learning
An observational study of Lung Transplantation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial summary
Since the first human lung transplantation in 1963, significant advancements in immunosuppressive agents from the mid-1990s have greatly improved the quantity and quality of such procedures. In 2004, a total of 1,815 lung transplantations were globally reported. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- General anesthesia
- How many people
- 214 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Jan 2024to 30 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease
Who may be able to join
- Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction Model for Postoperative Pulmonary Complications in Patients Undergoing Lung Transplantation Using Machine Learning: a Retrospective Cohort Study
Since the first human lung transplantation in 1963, significant advancements in immunosuppressive agents from the mid-1990s have greatly improved the quantity and quality of such procedures. In 2004, a total of 1,815 lung transplantations were globally reported. Patients undergoing this procedure are typically elderly and experience not only impaired lung function but also overall health instability. Despite successful outcomes, postoperative pulmonary complications (PPCs) can lead to serious consequences, including deterioration and fatality. PPCs resulting from lung transplantation may lead to prolonged hospitalization, increased complications, and the need for additional treatment. Various factors, such as age, smoking, pre-existing lung diseases, immunosuppressive drug use, diabetes, hypertension, infections, allergies, and immune disorders, are associated with the development of PPCs. The retrospective analysis of medical records from adult patients who underwent lung transplantation aims to investigate patient characteristics, anesthesia methods, intraoperative tests, and the occurrence of PPCs, with the ultimate goal of analyzing the incidence and risk factors of postoperative respiratory complications and developing a predictive model through machine learning.
Read the detailed description
After the first report of lung transplantation in humans in 1963, rapid advancements in immunosuppressive agents since the mid-1990s have led to significant progress in both the quantity and quality of lung transplantation. In 2004, a total of 1,815 lung transplantations were reported worldwide. Patients undergoing lung transplantation are typically elderly, often experiencing not only impaired lung function but also overall instability in their health. Despite successful outcomes in lung transplantation, the occurrence of pulmonary complications after surgery can lead to deterioration or even fatal consequences.
Postoperative pulmonary complications (PPCs) can result in prolonged hospitalization, increased complications, and the need for additional treatment. Various factors are associated with the development of PPCs after lung transplantation, including age, smoking, pre-existing lung diseases (such as chronic obstructive pulmonary disease, pulmonary fibrosis, etc.), immunosuppressive drug use post-transplant, diabetes, hypertension, pulmonary hypertension, heart disease, infections, allergies, and immune disorders. The retrospective analysis of medical records of adult patients who underwent lung transplantation aims to investigate patient characteristics, anesthesia methods, intraoperative tests, and the occurrence of PPCs. The goal is to analyze the incidence and risk factors of postoperative respiratory complications and develop a predictive model through machine learning.
- Conditions
- Lung Transplantation
- Being tested
- General anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
General anesthesiaOther
General anesthesia using 2% propofol, and remifentanil for lung transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pulmonary complications
Postoperative pulmonary complications such as pleural effusion, pneumothorax, hemothorax, chylothorax, atelectasis, pulmonary edema, acute respiratory distress syndrome, pneumonia, bronchial stenosis, pulmonary fibrosis and emphysema, postoperative tracheostomy, acute rejection occurring within the first year after lung transplantation, chronic rejection
Measured: Up to 1 year after lung transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start22 Jan 2024
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kim Hee Young, Pusan National University Yangsan Hospital
- Investigators
- Hee Young Kim, MD, PhD, Principal investigator, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218758
- Sponsor's protocol ID
- 55-2024-004
- Status last verified
- Jul 2025
- First submitted
- 12 Jan 2024
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction Model for Postoperative Pulmonary Complications in Patients Undergoing Lung Transplantation Using Machine Learning: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06218758
- Acronym / sponsor ID
- 55-2024-004
- Conditions
- Lung Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 23 Jan 2024 (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.
Since the first human lung transplantation in 1963, significant advancements in immunosuppressive agents from the mid-1990s have greatly improved the quantity and quality of such procedures. In 2004, a total of 1,815 lung transplantations were globally reported. Patients undergoing this procedure are typically elderly and experience not only impaired lung function but also overall health instability. Despite successful outcomes, postoperative pulmonary complications (PPCs) can lead to serious consequences, including deterioration and fatality. PPCs resulting from lung transplantation may lead to prolonged hospitalization, increased complications, and the need for additional treatment. Various factors, such as age, smoking, pre-existing lung diseases, immunosuppressive drug use, diabetes, hypertension, infections, allergies, and immune disorders, are associated with the development of PPCs. The retrospective analysis of medical records from adult patients who underwent lung transplantation aims to investigate patient characteristics, anesthesia methods, intraoperative tests, and the occurrence of PPCs, with the ultimate goal of analyzing the incidence and risk factors of postoperative respiratory complications and developing a predictive model through machine learning.
Detailed description
After the first report of lung transplantation in humans in 1963, rapid advancements in immunosuppressive agents since the mid-1990s have led to significant progress in both the quantity and quality of lung transplantation. In 2004, a total of 1,815 lung transplantations were reported worldwide. Patients undergoing lung transplantation are typically elderly, often experiencing not only impaired lung function but also overall instability in their health. Despite successful outcomes in lung transplantation, the occurrence of pulmonary complications after surgery can lead to deterioration or even fatal consequences.
Postoperative pulmonary complications (PPCs) can result in prolonged hospitalization, increased complications, and the need for additional treatment. Various factors are associated with the development of PPCs after lung transplantation, including age, smoking, pre-existing lung diseases (such as chronic obstructive pulmonary disease, pulmonary fibrosis, etc.), immunosuppressive drug use post-transplant, diabetes, hypertension, pulmonary hypertension, heart disease, infections, allergies, and immune disorders. The retrospective analysis of medical records of adult patients who underwent lung transplantation aims to investigate patient characteristics, anesthesia methods, intraoperative tests, and the occurrence of PPCs. The goal is to analyze the incidence and risk factors of postoperative respiratory complications and develop a predictive model through machine learning.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease
Key inclusion criteria (1 listed)
- Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| General anesthesiaGeneral anesthesia using 2% propofol, and remifentanil for lung transplantation | Other | – |
Primary outcome
Postoperative pulmonary complications
Time frame: Up to 1 year after lung transplantation
Postoperative pulmonary complications such as pleural effusion, pneumothorax, hemothorax, chylothorax, atelectasis, pulmonary edema, acute respiratory distress syndrome, pneumonia, bronchial stenosis, pulmonary fibrosis and emphysema, postoperative tracheostomy, acute rejection occurring within the first year after lung transplantation, chronic rejection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Lung Transplantation
Not yet recruiting
Bioimpedance and Multiparametric Ultrasound-Guided Fluid Management After Kidney Transplantation
Kidney Transplantation, Delayed Graft Function
RecruitingPhase 1
Syk Inhibition in MItigating Lung Allograft Rejection (SIMILAR): A Trial to Evaluate the Safety and Tolerability of Fostamatinib in Lung Transplant Patients With Donor-Specific Antibodies
Lung Transplantation
RecruitingPhase 3
A Study to Test How Effective Belumosudil Tablets Are for Treating Adult Participants With Chronic Lung Allograft Dysfunction
Lung Transplant Rejection
Active, not recruitingPhase 3
RSV Vaccine in Transplant Recipients
Vaccine Response Impaired, Respiratory Syncytial Virus Infections
Not yet recruitingPhase 2
Immune Checkpoint Blockade and Chemotherapy With or Without Fecal Microbiota Transplant in Advanced Non-Small Cell Lung Cancer
Non Small Cell Lung Cancer
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. This study is not recruiting at the moment.
Hee Young Kim, MD, PhD principal investigator
Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University
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 Lung Transplantation, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 1 Aug 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pulmonary complications (time frame: Up to 1 year after lung transplantation). 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 1 Aug 2025.