Skip to content

Digital Early Warning System for Acute Lung Injury in Liver Surgery

The Construction of a Digital Intelligence Early Warning System for the Whole Process of Acute Lung Injury in Liver Surgery Based on Cardiopulmonary Interaction Characteristics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07070362
Enrollment
4000
Registered
2025-07-17
Start date
2024-11-01
Completion date
2027-11-30
Last updated
2025-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Digital Intelligence, Acute Lung Injury, PPCs, Liver Surgery, Cardiopulmonary Interaction;

Brief summary

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.

Detailed 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.

Interventions

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.

Sponsors

Beijing Tsinghua Chang Gung Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Occurrence of ALI within 7 Days after SurgeryPerioperative 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).Berlin Definition: 1. Onset: Acute exacerbation of known injury or new/worsening respiratory symptoms within 1 week. 2. Chest Imaging (X-ray or CT): Bilateral pulmonary shadows not fully explained by exudation, atelectasis, or nodules. 3. Pulmonary Edema Etiology: Respiratory failure not fully attributed to heart failure or fluid overload; if no related risk factors, objective tests (e.g., Doppler echocardiography) are needed to exclude hydrostatic pulmonary edema. 4. Oxygenation Levels: Mild - With CPAP/PEEP \>5 cmH2O, 200 mmHg \< PaO2/FiO2 \< 300 mmHg; Moderate - With CPAP/PEEP \>5 cmH2O, 100 mmHg \< PaO2/FiO2 \< 200 mmHg; Severe - With CPAP/PEEP \>5 cmH2O, PaO2/FiO2 \< 100 mmHg.

Countries

China

Contacts

Primary ContactGao Zhifeng, MD
btchgzf@hotmail.com+8615801249466

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026