Digital Early Warning System for Acute Lung Injury in Liver Surgery

Beijing Tsinghua Chang Gung Hospital

Status: Enrolling

Conditions: Liver Cirrhosis; NAFLD (Nonalcoholic Fatty Liver Disease); Liver Cancer, Adult; MASLD; ARDS, Human; MASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis); Acute Lung Injury(ALI)

Treatments: Other: None-placebo

Study type: Observational

Funder types: Other

Identifiers

NCT07070362

25254-0-01 (Other Identifier)

BRWEP2024W032240113

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 4,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Age ≥ 18 years
• Undergoing major liver surgery (including two-segment or more hepatectomy, liver transplantation, etc.)
• Voluntary participation with signed informed consent

Trial design

4,000 participants in 1 patient group

patients undergoing major liver surgury

Description:

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.

Treatment:

Other: None-placebo