Prediction Model for PPCs in Patients Undergoing Lung Transplantation Using Machine Learning

Lung Transplantation Clinical Trial

Official title:

Prediction Model for Postoperative Pulmonary Complications in Patients Undergoing Lung Transplantation Using Machine Learning: a Retrospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06218758
• Other study ID #: 55-2024-004
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Pusan National University Yangsan Hospital
• Contact: Hee Young Kim, MD, PhD
• Phone: 82-10-7641-1774
• Email: anekhy[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients 18 years of age or older who underwent lung transplantation for end-stage lung disease

Exclusion Criteria:

• None.

Related Conditions & MeSH terms

• Lung Transplantation

Intervention

Other:
• General anesthesia
General anesthesia using 2% propofol, and remifentanil for lung transplantation

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Yangsan Hospital	Yangsan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Yangsan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Up to 1 year after lung transplantation