Trial · NCT07898319
Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
NCT07898319, Not yet recruiting, Ruijin Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Development and Prospective Validation of the AutoEIT Foundation Model for ARDS. Trials, record NCT07898319. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07898319
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Development and Prospective Validation of the AutoEIT Foundation Model for ARDS
- NCT number
- NCT07898319
- Status
- Not yet recruiting
- Enrollment
- 1,200 participants, estimated
- Lead sponsor
- Ruijin Hospital
- Conditions
- ARDS (Acute Respiratory Distress Syndrome), Respiratory Failure, Mechanical Ventilation, Ventilator-induced Lung Injury (VILI)
- Interventions
- AutoEIT Model Training, AutoEIT Blinded Validation
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Diagnostic Performance of ARDS Subphenotype Classification | At baseline, within 24 hours of ARDS diagnosis or Intensive Care Unit (ICU) admission. | Area Under the Receiver Operating Characteristic curve (AUC-ROC) of the AutoEIT model for classifying ARDS subphenotypes into hyperinflammatory versus hypoinflammatory phenotypes, using latent class analysis (LCA) based on clinical and biomarker data as the reference ground truth. AUC-ROC will be calculated with 95% confidence intervals using DeLong's method. A predefined threshold of AUC-ROC ≥ 0.80 will be considered clinically acceptable.Unit of Measure: AUC-ROC (dimensionless, 0 to 1) |
| Primary | Accuracy of Optimal PEEP Recommendation | At the time of the first standardized decremental PEEP trial, within 72 hours of enrollment. | Root Mean Square Error (RMSE) between the AutoEIT-recommended positive end-expiratory pressure (PEEP) and the clinically optimal PEEP derived from the intersection point of lung collapse and overdistension curves obtained during a standardized decremental PEEP trial. RMSE will be calculated in cmH2O; lower values indicate better agreement. A clinically acceptable RMSE threshold is predefined as ≤ 2.0 cmH2O.Unit of Measure: cmH2O |
| Primary | Detection Accuracy of Patient-Ventilator Asynchrony | Throughout the EIT monitoring period, within 72 hours of enrollment. | Area Under the Receiver Operating Characteristic curve (AUC-ROC) of the AutoEIT model for detecting occult patient-ventilator asynchrony events, including pendelluft, breath-stacking, and ineffective triggering, validated independently against blinded expert review of synchronized video, EIT images, and ventilator waveforms by two intensivists. AUC-ROC will be calculated with 95% confidence intervals. A predefined threshold of AUC-ROC ≥ 0.85 will be considered clinically acceptable.Unit of Measure: AUC-ROC (dimensionless, 0 to 1) |
| Primary | Accuracy of V/Q Ratio Prediction | Throughout the EIT monitoring period, within 72 hours of enrollment. | Pearson Correlation Coefficient (PCC) between the AutoEIT-predicted ventilation/perfusion (V/Q) ratio and the physiological ground truth measured by the reference multiple inert gas elimination technique (MIGET) or a surrogate method. PCC will be calculated with 95% confidence intervals using Fisher's z-transformation. A predefined threshold of PCC ≥ 0.70 will be considered clinically acceptable.Unit of Measure: PCC (dimensionless, range -1 to 1) |
| Primary | Accuracy of Non-invasive PaO2/FiO2 Ratio Prediction | Throughout the EIT monitoring period, within 72 hours of enrollment. | Root Mean Square Error (RMSE) between the AutoEIT-predicted non-invasive PaO2/FiO2 ratio and the simultaneously measured arterial blood gas (ABG) PaO2/FiO2 ratio. RMSE will be calculated in mmHg; lower values indicate better agreement. A clinically acceptable RMSE threshold is predefined as ≤ 20 mmHg.Unit of Measure: mmHg |
| Secondary | Prognostic Association with 28-Day Ventilator-Free Days (VFDs) | From enrollment to the end of treatment at day 28. | Correlation between AutoEIT-derived dynamic spatiotemporal features extracted from the foundation model embeddings and the number of ventilator-free days (VFDs) at day 28, defined as the number of days from successful weaning to day 28 during which the patient is alive and free from invasive mechanical ventilation. The association will be assessed using multivariable linear regression models adjusted for Acute Physiology and Chronic Health Evaluation II (APACHE II) score, age, and baseline PaO2/FiO2 ratio. Partial correlation coefficients (r) and 95% confidence intervals will be reported.Unit of Measure: Days (continuous) |
| Secondary | Intensive Care Unit (ICU) All-Cause Mortality Prediction | From ICU admission to ICU discharge or death, assessed up to day 28. | Predictive value of AutoEIT-derived subphenotypes, hyperinflammatory versus hypoinflammatory, for ICU all-cause mortality, assessed using Cox proportional hazards regression models. Hazard ratios (HR) with 95% confidence intervals will be reported for the association between subphenotype and mortality, adjusted for age, APACHE II score, and vasopressor use.Hazard ratio (HR, dimensionless) |
| Secondary | 28-Day All-Cause Mortality Prediction | From enrollment to day 28. | Predictive value of AutoEIT-derived subphenotypes, hyperinflammatory versus hypoinflammatory, for 28-day all-cause mortality, assessed using Cox proportional hazards regression models. Hazard ratios (HR) with 95% confidence intervals will be reported for the association between subphenotype and mortality, adjusted for age, APACHE II score, and vasopressor use. Cumulative incidence of mortality will be visualized using Kaplan-Meier curves, and the log-rank test will be used to compare survival distributions between subphenotypes.Hazard ratio (HR, dimensionless) |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07898319
GET https://conductscience.org/api/trials/v1/NCT07898319/registered