Abstract
Background: Sepsis commonly causes acute respiratory distress syndrome (ARDS), and ARDS contributes to poor prognosis in sepsis patients. Early prediction of ARDS for sepsis patients remains a clinical challenge. This study aims to develop and validate chest computed tomography (CT) radiomic-based signatures for early prediction of ARDS and assessment of individual severity in sepsis patients. Methods: In this ambispective observational cohort study, a deep learning model, a sepsis-induced acute respiratory distress syndrome (SI-ARDS) prediction neural network, will be developed to extract radiomics features of chest CT from sepsis patients. The datasets will be collected from these retrospective and prospective cohorts, including 400 patients diagnosed with sepsis-3 definition during a period from 1 May 2015 to 30 May 2022. 160 patients of the retrospective cohort will be selected as a discovering group to reconstruct the model and 40 patients of the retrospective cohort will be selected as a testing group for internal validation. Additionally, 200 patients of the prospective cohort from two hospitals will be selected as a validating group for external validation. Data pertaining to chest CT, clinical information, immune-associated inflammatory indicators and follow-up will be collected. The primary outcome is to develop and validate the model, predicting in-hospital incidence of SI-ARDS. Finally, model performance will be evaluated using the area under the curve (AUC) of receiver operating characteristic (ROC), sensitivity and specificity, using internal and external validations. Discussion: Present studies reveal that early identification and classification of the SI-ARDS is essential to improve prognosis and disease management. Chest CT has been sought as a useful diagnostic tool to identify ARDS. However, when characteristic imaging findings were clearly presented, delays in diagnosis and treatment were impossible to avoid. In this ambispective cohort study, we hope to develop a novel model incorporating radiomic signatures and clinical signatures to provide an easy-to-use and individualized prediction of SI-ARDS occurrence and severe degree in patients at early stage.