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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06218758
Other study ID # 55-2024-004
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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