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| ID | Type | Description | Link |
|---|---|---|---|
| 25254-0-01 | Other Identifier | Ethics Committee of Beijing Tsinghua Changgung Hospital |
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This study focuses on developing an explainable machine learning model based on cardiopulmonary interaction characteristics to achieve early prediction of acute lung injury (ALI) in patients undergoing major liver surgery. The research will establish a digital early-warning system for ALI to provide support for clinical diagnosis and treatment decisions, thereby reducing the incidence and fatality rate of ALI.
This study will leverage cardiopulmonary interaction parameters to predict ALI in patients undergoing major liver surgery. Specifically, the research will collect data from preoperative, intraoperative, and postoperative phases. Machine learning algorithms-including logistic regression, random forest, support vector machines (SVM), and neural networks-will be used to develop and validate the prediction model. Model performance will be evaluated using metrics such as accuracy, sensitivity, specificity, and the receiver operating characteristic (ROC) curve. The ultimate objective is to develop a highly accurate and interpretable model that can be integrated into a digital early-warning system for clinical application.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients undergoing major liver surgury | Population: 2,497 adult patients (≥18 years) who underwent major liver surgery (≥2 segments resection or transplantation) at Beijing Tsinghua Changgung Hospital, including retrospective (2019.06-2024.05) and prospective (from 2025.12) cohorts. Inclusion Criteria: Aged ≥18, scheduled for major liver surgery, with informed consent. Exclusion Criteria: Refusal to participate, comorbidities affecting ALI assessment, incomplete data, failed follow-up, or concurrent trials. Interventions: None. Observational study; clinical management follows standard protocols without study-related interventions. Data collected from routine records and monitoring. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None-placebo | Other | This observational cohort study is non-interventional. Perioperative treatment plans are made based on model - suggested results and anesthesiologists' thought processes, without adding new medicines for patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of ALI within 7 Days after Surgery | Berlin Definition:
| Perioperative period (Perioperative): Refers to the entire process from the determination of surgical treatment to postoperative rehabilitation (e.g., from 1 day before surgery to 7 days after surgery). |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gao Zhifeng, MD | Contact | +8615801249466 | btchgzf@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsinghua University | Recruiting | Beijing | Beijing Municipality | 102218 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 27, 2025 | Jul 8, 2025 |
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3-6ml blood
| Prot_000.pdf |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D008103 | Liver Cirrhosis |
| D012128 | Respiratory Distress Syndrome |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012120 | Respiration Disorders |
| D005234 | Fatty Liver |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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