Digital Early Warning System for Acute Lung Injury in Liver Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBeijing Tsinghua Chang Gung Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years

Undergoing major liver surgery (including two-segment or more hepatectomy, liver transplantation, etc.)

Voluntary participation with signed informed consent

Disqualifiers

None

Trial 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

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

3,000 Participants
are grouped into 2 trial groups
Group A: Multicentre External Validation Cohort
Group B: BTCH Development and Validation Cohort

Trial outcomes

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.

Time frame
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).

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tsinghua Chang Gung Hospital

Lead sponsor

Huangdao District People's Hospital of Qingdao

Collaborator

Peking University International Hospital

Collaborator

The First Affiliated Hospital of Army Medical University (Southwest Hospital)

Collaborator