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临床试验/NCT06633848
NCT06633848
尚未招募
不适用

Establishment of Artificial Intelligence Algorithms Based Clinical Prediction Model for Patients with Postoperative Symptomatic Spinal Epidural Hematoma After Spinal Surgery

Peking University Third Hospital0 个研究点目标入组 2,000 人2025年1月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
Spinal Epidural Hematoma
发起方
Peking University Third Hospital
入组人数
2000
主要终点
if the patients have postoperative symptomatic spinal epidural hematoma
状态
尚未招募
最后更新
去年

概览

简要总结

The goal of this observational study is to establish a clinical prediction model based on artificial intelligence algorithms for patients with postoperative symptomatic spinal epidural hematoma(PSSEH) after spinal surgery. The investigators will collect the features of 2000 patients as the training set to train the models using AI algorithms, then recruit a prospective cohort of 2000 patients to test if the trained model is precise and consistent to predict the occurrence of PSSEH as well as to find out whether there is any new risk factor of PSSEH.

详细描述

Firstly, the investigators plan to collect the features of 2000 patients who received spinal surgery at Peking University Third Hospital from January 2014 to December 2024, including those with PSSEH and the controls, as the training set to build up a prediction model based on multiple AI algorithms. Then, the investigators will choose the optimal model through comparing various features, assessing the robustness of the model quantitatively using k-fold cross validation and exploring the influence of all features on the output of the final model by means such as SHAP. Lastly, the investigators will recruit a prospective cohort of approximately 2000 patients who receive spinal surgery from January 2025 to December 2026 at Peking University Third Hospital and collect the same features as the training set to test if the trained prediction model is precise and consistent to predict the occurrence of PSSEH and whether there is any feature , undiscovered before, that is strongly related to PSSEH.

注册库
clinicaltrials.gov
开始日期
2025年1月1日
结束日期
2026年12月31日
最后更新
去年
研究类型
Observational
性别
All

研究者

责任方
Sponsor

入排标准

入选标准

  • patients who will receive spinal surgery from January 2025 to December 2026 at Peking University Third Hospital

排除标准

  • patients with a history of lumbar trauma before admission;
  • patients who suffer from malignant tumor;
  • patients with systemic infection;
  • patients who quit the study midway

结局指标

主要结局

if the patients have postoperative symptomatic spinal epidural hematoma

时间窗: within 2 weeks after spinal surgery

patients with symptoms as below: 1. Persistent wound bleeding; 2. Exacerbation of wound pain; 3. Radicular symptoms-severe low back pain, shoulder and neck pain; 4. Motor dysfunction-limb muscle weakness, muscle atrophy; 5. Sensory abnormalities-reduced or lost tactile sensation, pain, and temperature perception; 6. pharyngeal discomfort, shortness of breath, and difficulty breathing; 7. Urinary and bowel dysfunction-urinary retention, urinary incontinence, dysporia; 8. Hematoma compressing the dura mater discovered during hematoma evacuation surgery; 9. Suspected PSSEH based on the surgeon's assessment; 10. Definitive diagnosis by MRI imaging;

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