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临床试验/NCT07321262
NCT07321262已完成不适用

An Interpretable and Clinically Deployable Machine Learning Model for Predicting Early Postoperative Pneumonia of Brain Tumor: a Multicenter Diagnostic Study

Ming Yang1 个研究点 分布在 1 个国家目标入组 1,856 人开始时间: 2024年8月1日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,856
试验地点
1
主要终点
Incidence of early postoperative pneumonia (POP)

研究概览

简要总结

Postoperative pneumonia (POP) is a common and serious complication after elective craniotomy for brain tumor resection. POP often develops within the first week after surgery and may lead to prolonged hospitalization, higher medical costs, and increased risk of severe illness. Because symptoms can be subtle in neurosurgical patients, POP may be detected late, limiting timely prevention and treatment.

This study will evaluate whether a machine-learning-based clinical decision support tool can help clinicians identify patients at high risk for POP early and improve perioperative preventive care. The tool uses routinely collected clinical information to estimate an individual patient's POP risk and provides an easy-to-understand explanation of key risk drivers. Based on the predicted risk level (low, moderate, high, or very high), the system suggests standardized preventive care pathways (e.g., perioperative airway management, targeted antibiotic strategies per local practice, and nutritional support), while allowing clinicians to override recommendations at any time.

Participants will be adults undergoing their first elective craniotomy for brain tumor resection at participating neurosurgical centers. The primary outcome is the occurrence of POP within 7 days after surgery, defined using CDC/NHSN criteria. Secondary outcomes include antibiotic use intensity, length of hospital stay, direct medical cost, and clinician decision confidence. Participants will be followed at postoperative days 1, 3, and 7 using electronic medical record review and phone confirmation when needed.

The goal of this study is to determine whether integrating an explainable AI risk prediction tool into routine care can reduce POP and improve the quality and efficiency of perioperative management after brain tumor surgery.

详细描述

Rationale Postoperative pneumonia (POP) remains a frequent and clinically important complication after elective craniotomy for brain tumor resection, contributing to prolonged hospitalization, increased cost, and worse clinical outcomes. Conventional POP risk assessment is often experience-based or relies on simplified scoring approaches, which may not adequately capture nonlinear interactions among perioperative factors. This study implements an explainable machine-learning (ML) prediction model within routine perioperative workflows and evaluates whether model-assisted care can improve POP prevention and related resource utilization compared with usual care.

Decision support system

An explainable gradient boosting machine (GBM) model is used to estimate individual POP risk from routinely available perioperative variables. Interpretability is provided using SHAP-based explanations at two complementary levels:

Population level: summarizes the most influential predictors and selected interaction patterns to support clinical understanding and model governance.

Patient level: generates an individualized contribution visualization (e.g., waterfall-style), highlighting the main drivers of a specific patient's risk estimate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Undergoing elective craniotomy for intracranial brain tumor resection.
  • Perioperative clinical data available in the electronic medical record to derive required predictors.
  • Expected postoperative survival ≥ 7 days.

排除标准

  • Evidence of active infection (including pneumonia) prior to surgery.
  • Thoracic surgery or severe chest trauma within 30 days prior to craniotomy.
  • Spinal tumors or extracranial peripheral nerve tumors.
  • Pregnancy or lactation.
  • Hospice care, expected survival < 7 days, or insufficient data completeness for model calculation.

结局指标

主要结局

Incidence of early postoperative pneumonia (POP)

时间窗: Within 7 days after craniotomy (postoperative day 0-7)

Early POP was diagnosed according to CDC criteria and recorded in the electronic medical record, assessed as a binary outcome (POP vs no POP) within 7 postoperative days.

次要结局

  • Calibration performance of the finalized prediction model(Within 7 days after craniotomy (postoperative day 0-7))
  • Clinical utility of the finalized prediction model (Decision Curve Analysis)(Within 7 days after craniotomy (postoperative day 0-7))
  • Discrimination of the finalized prediction model (AUC)(Within 7 days after craniotomy (postoperative day 0-7))
  • Classification performance of the finalized prediction model at a pre-specified cutoff(Within 7 days after craniotomy (postoperative day 0-7))

研究者

发起方
Ming Yang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Ming Yang

Clinical Professor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

研究点 (1)

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