ClinicalTrials.gg
RecruitingNCT07070362Updated Aug 17, 2026

Digital Early Warning System for Acute Lung Injury in Liver Surgery

An observational study in Acute Lung Injury(ALI), Liver Cirrhosis and ARDS, Human, sponsored by Beijing Tsinghua Chang Gung Hospital. Recruiting at 4 sites in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.

Sponsored by Beijing Tsinghua Chang Gung Hospital · Observational

From the registry’s dates

  • Started Nov 2024; still recruiting 2 years later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
3,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 59 studies in Acute Lung Injury with a site in China — 20 open to participants now, 20 under way, 1 of them phase 3. Acute Lung Injury · China.

Planned enrollment
2nd of 28
3,000 · median 103
Started
2024
with 7 others
Observational
28 of 59
10 open now
Primary completion
2027-06
later than 12 of 19 live
Registered
45th of 59
by date

Among the 59 studies in Acute Lung Injury with a site in China, this one is the 2nd largest by planned enrollment of the 28 observational ones that give a count, is one of 8 that started in 2024, is one of 28 observational ones, reaches primary completion later than 12 of the 19 other live ones, and was the 45th registered.

Acute Lung Injury

382 studies on the registry are indexed under Acute Lung Injury; 73 are open to participants now.

Browse Acute Lung Injury studies →

Open to participants now

20 of the 59 studies in Acute Lung Injury with a site in China are open now. Recruiting first, the newest first:

14 more — sign in →

All 20 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 45 Acute Lung Injury studies recruiting now, 25 (56%) set no upper age limit and 8 (18%) stop at 75 or younger; 6 take children under 18; 7 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 59 studies in Acute Lung Injury with a site in China, or all of them as a file.
02

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.

Read the detailed description

This study will leverage 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.

03

Conditions studied

  • 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;
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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

Eligibility criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Undergoing major liver surgery (including two-segment or more hepatectomy, liver transplantation, etc.)
  • Voluntary participation with signed
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
3,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Multicentre External Validation Cohort

    Consecutive eligible adults who underwent major hepatobiliary or pancreatic surgery or liver transplantation at three independent external centres: Peking University International Hospital (WYA), Southwest Hospital of Army Medical University (WYB), and Huangdao District People's Hospital of Qingdao (WYC). The frozen full perioperative M3 model developed at BTCH was applied using the same predictor definitions, imputation rules, model parameters, and classification threshold, without centre-specific model fitting or recalibration. Centre-specific and pooled validation analyses were performed. This was a retrospective observational cohort; no intervention was assigned and routine clinical care was not altered.

  • BTCH Development and Validation Cohort

    Consecutive eligible adults who underwent major hepatobiliary or pancreatic surgery or liver transplantation at Beijing Tsinghua Changgung Hospital (BTCH) between October 16, 2015, and December 24, 2025. The earliest 70% formed the development cohort and the most recent 30% formed the temporal-validation cohort. Model development was confined to the development cohort, and the frozen models were evaluated in the temporal-validation cohort. This was a retrospective observational study; no intervention was assigned and routine clinical care was not altered.

06

What researchers measure

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).

07

Study locations

4 of 4 sites recruiting
  • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Medicine,Tsinghua University
    Beijing, Beijing Municipality 102218, China
    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
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Nov 2024 (actual). Primary completion is estimated for Jun 2027, 31 months after the start.

Of 41 non-industry observational studies under Acute Lung Injury, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 47. This study's planned 31 months is above that.

Counting every sponsor, half of 46 studies reached it within 18 months; a quarter within 8 and three quarters within 47.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 11, 2025
First posted
Jul 17, 2025
StartActual
Nov 1, 2024
Primary completionEst.
Jun 1, 2027
CompletionEst.
Nov 30, 2027
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07070362
Collaborators
Huangdao District People's Hospital of Qingdao, Peking University International Hospital, The First Affiliated Hospital of Army Medical University (Southwest Hospital)
Responsible party
Zhifeng Gao (Chief physician, Beijing Tsinghua Chang Gung Hospital) — Principal investigator
First posted
Jul 17, 2025
Start date
Nov 1, 2024
Primary completion
Jun 1, 2027 (estimated)
Completion
Nov 30, 2027 (estimated)
Last update
Aug 17, 2026

Study contacts

Gao Zhifeng, MD
Contact
btchgzf@hotmail.com
+8615801249466

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion