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Recruiting Observational

Digital Early Warning System for Acute Lung Injury in Liver Surgery

NCT07070362 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-11-01
Last updated
2026-08-17

Condition(s) studied

Acute Lung Injury(ALI)Liver CirrhosisARDS, HumanMASLDMASLD/MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease / Metabolic Dysfunction-Associated Steatohepatitis)NAFLD (Nonalcoholic Fatty Liver Disease)Liver Cancer, Adult

Study summary

This study aims to develop an explainable machine learning model that takes into account the characteristics of cardiopulmonary interactions. This model will enable early prediction of acute lung injury (ALI) in patients undergoing major liver surgery. The research will create a digital early-warning system for ALI, thereby supporting clinical diagnosis and treatment decisions. This, in turn, should help reduce the incidence and mortality rates associated with ALI.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

  • Occurrence of ALI within 7 Days after Surgery — 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).
    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.

Trial sites (4)

FacilityCityRegionStatus
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsinghua University Beijing Beijing Municipality Recruiting
Peking University International Hospital Beijing China Recruiting
Southwest Hospital, The First Affiliated Hospital of Army Medical University Chongqing China Recruiting
Huangdao District People's Hospital of Qingdao Qingdao China Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07070362 on ClinicalTrials.gov ↗ ← All trials in China