Digital Early Warning System for Acute Lung Injury in Liver Surgery

NCT07070362 | Recruiting

• 2 other identifiers: BRWEP2024W03224011325254-0-01
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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.

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;

Outcome Measures

Primary Outcomes (1)

• Occurrence of ALI within 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.

  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).

Study Arms (1)

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.

Other: None-placebo

Interventions

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.

patients undergoing major liver surgury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patient refusal * Presence of comorbidities affecting outcome assessment * Incomplete outcome records * Postoperative follow-up failure * Participation in other studies that may interfere with outcome assessment

You may qualify if:

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

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine，Tsinghua University

Beijing, Beijing Municipality, 102218, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

3-6ml blood

MeSH Terms

Conditions

Acute Lung Injury; Liver Cirrhosis; Respiratory Distress Syndrome; Non-alcoholic Fatty Liver Disease; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Lung Injury; Lung Diseases; Respiratory Tract Diseases; Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Fatty Liver; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site

Central Study Contacts

Gao Zhifeng, MD

CONTACT

+8615801249466; btchgzf@hotmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: July 17, 2025
• Study Start: November 1, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: July 17, 2025

Record last verified: 2025-07

Locations

CN (1)