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Clinical Trials/NCT06226480
NCT06226480
Completed
Not Applicable

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

Affiliated Hospital of Nantong University1 site in 1 country3,967 target enrollmentFebruary 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Postoperative Delirium
Sponsor
Affiliated Hospital of Nantong University
Enrollment
3967
Locations
1
Primary Endpoint
Number of participants with postoperative delirium
Status
Completed
Last Updated
last year

Overview

Brief 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.

Detailed 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.

Registry
clinicaltrials.gov
Start Date
February 25, 2024
End Date
July 31, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of participants with postoperative delirium

Time Frame: The first three postoperative days

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.

Study Sites (1)

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