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

January 24, 2024 updated by: Kim Hee Young, Pusan National University Yangsan Hospital

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.

Study Overview

Status

Recruiting

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

214

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hee Young Kim, MD, PhD
  • Phone Number: 82-10-7641-1774
  • Email: anekhy@gmail.com

Study Contact Backup

  • Name: Hee Young Kim
  • Phone Number: 8255360219

Study Locations

      • Yangsan, Korea, Republic of
        • Recruiting
        • Pusan National University Yangsan Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 1 year after lung transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hee Young Kim, MD, PhD, Department of Anesthesia and Pain Medicine, School of Medicine, Pusan National University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

January 12, 2024

First Submitted That Met QC Criteria

January 22, 2024

First Posted (Actual)

January 23, 2024

Study Record Updates

Last Update Posted (Actual)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 55-2024-004

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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