Machine Learning Algorithm for Predicting Postoperative Delirium in Elderly Patients After Thoracic Surgery

Postoperative Delirium Clinical Trial

— POD  

Official title:

Development and Validation of a Prediction Model for Postoperative Delirium in Elderly Patients After Thoracic Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06226480
• Other study ID #: 2024-K002-01
• Secondary ID: YJXYY202204-YSC0
• Status: Recruiting
• Start date: February 25, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: January 2024
• Source: Affiliated Hospital of Nantong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Postoperative delirium (POD) is a common and severe complication in patients undergoing major surgery, especially in the elderly. POD has been proven to be associated with increased morbidity and mortality, institutionalization, and high healthcare costs. This retrospective cohort study aimed to use machine learning methods to develop clinically meaningful models to support clinical decision making.

Description:

The primary outcome was the incidence of POD within 3 days postoperatively. The patients will be randomly split into two datasets with split ratios of 80% and 20%.

Subsequently, 80% of the patients will be used for training, and 20% of the patients will be used for testing. Multiple machine learning algorithms will be used to develop POD risk prediction models. The discrimination ability of the prediction models will be assessed by calculating the area under the receiver operating characteristic curve (AUC). The calibration of the model will be evaluated using the Hosmer-Lemeshow goodness of fit test. Decision curve analysis (DCA) will be used to evaluate the net benefits for each threshold probability. The best model will be selected by comparing the performance between the models. Then the SHapley Additive exPlanations (SHAP) will be used to explain the best one.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3967
• Est. completion date: July 31, 2024
• Est. primary completion date: July 20, 2024
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• aged = 65 years

• elective segmentectomy, lobectomy, or esophagectomy surgeries

• general anesthesia

Exclusion Criteria:

• surgery length less than 1 hour

• preoperative cognitive dysfunction

• admission to the intensive care unit

• second operation within 24 hours

• missing data for any variables

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Postoperative Delirium

Locations

Country	Name	City	State
China	Affiliated Hospital of Nantong University	Nantong	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Nantong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with postoperative delirium	The following descriptive words and the derivatives were searched from the medical records: "delirium", "agitation", "hallucinations", "combative behavior", "inattention", "confusion", "mental status change", "disorientation", "drowsy". Medical records with the presence of these keywords were reviewed by an independent researcher, and medical records presented the aforementioned symptoms preoperatively were excluded. Postoperative delirium was diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria.	The first three postoperative days