Skip to main content
OpenTrials
Completed

NCT Number: NCT07321262

Machine Learning to Predict Postoperative Pneumonia in Brain Tumor Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

About this study

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.

The system automatically assigns a risk tier (low, moderate, high, or very high) and links each tier to standardized prevention pathway templates (e.g., airway management optimization, antimicrobial stewardship-consistent strategies per local policy, and nutritional support). The tool does not mandate treatment; clinicians may accept, modify, or override any suggestion.

Evaluation framework The overall project includes retrospective model development/optimization, prospective external validation/calibration, and a pragmatic implementation evaluation. The registered interventional evaluation uses a multicenter, cluster randomized crossover design with monthly alternating periods of model-assisted care versus usual care. Allocation procedures, eligibility criteria, planned enrollment, and endpoint definitions/time windows are specified in the corresponding record modules (Study Design, Arms/Interventions, Outcome Measures, and Eligibility) to avoid duplication in this section.

Implementation and integration The model is deployed as a lightweight web service with unified APIs and data-exchange formats to enable non-disruptive integration with hospital information systems (HIS) and electronic medical records (EMR). A web-based front end and a Python-based back end support RESTful calls and are designed for low-latency inference (target single-prediction latency <200 ms), suitable for perioperative and inpatient workflows.

Data governance and model updating To support long-term generalizability across hospitals and mitigate dataset shift, the project establishes a closed-loop maintenance process ("local de-identification → cloud retraining → model version management → edge deployment"). Model updates are version-controlled and deployed under governance procedures consistent with local regulations, institutional policies, and applicable ethics approvals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Incidence of early postoperative pneumonia (POP)

    Time frame: 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.

Secondary outcomes

  1. Discrimination of the finalized prediction model (AUC)

    Time frame: Within 7 days after craniotomy (postoperative day 0-7)

    Area under the receiver operating characteristic curve (AUC) for the finalized interpretable logistic regression model in predicting early POP (binary outcome within 7 days).

  2. Calibration performance of the finalized prediction model

    Time frame: Within 7 days after craniotomy (postoperative day 0-7)

    Calibration assessed using calibration curve and summary statistics (e.g., calibration intercept and slope; Brier score), comparing predicted probabilities with observed early POP outcomes.

  3. Clinical utility of the finalized prediction model (Decision Curve Analysis)

    Time frame: Within 7 days after craniotomy (postoperative day 0-7)

    Net benefit of the finalized model evaluated by decision curve analysis across clinically relevant threshold probabilities for early POP.

  4. Classification performance of the finalized prediction model at a pre-specified cutoff

    Time frame: Within 7 days after craniotomy (postoperative day 0-7)

    Sensitivity, specificity, accuracy, positive predictive value (PPV), negative predictive value (NPV), and F1 score calculated at a pre-specified probability threshold (e.g., determined in the training cohort using Youden index) and applied to validation cohorts.

Sponsors and collaborators

Lead sponsor

Ming Yang

Other

Collaborators

  • Shandong Cancer Hospital and Institute
  • The First Affiliated Hospital of Anhui Medical University

Registry information

Official study title

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

Acronym: ML-PNEUMO-BT

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 7, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.