Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-25 @ 5:05 AM
Ignite Modification Date: 2025-12-25 @ 5:05 AM
NCT ID: NCT06814327
Brief Summary: During this observational study, the investigators aim to assess the ability of ICU clinicians to predict the risk of impending organ failure and retrospectively compare it to the performance of previously published machine learning models. The central hypothesis of this study is that the treating physician can predict impending organ failure in adult ICU patients with similar accuracy as the best previously publishes machine learning models.
Detailed Description: In this observational study, clinician's (physicians and nurses) assessment of the estimated imminent organ failure risk in an ICU setting are prospectively collected. Circulatory failure is investigated in the primary objective, and respiratory failure, renal failure, and mortality are investigated in secondary objectives. These assessments investigate the predictive performance and influencing factors for clinician prediction. The assessments will be collected in questionnaires and be performed by the clinicians directly involved in the patient treatment and by clinicians who are not actively responsible for the patient treatment. Furthermore, this study aims to benchmark these risk assessments made by healthcare professionals against retrospectively generated AI risk scores for the same patients and timepoints. The AI risk scores will be calculated retrospectively from a set of models from a systematic search of the current literature. The AI models that will be employed for this analysis will be identified as indicated by a systematic review protocol and must satisfy the following two criteria: they do not require any data beyond what is routinely collected during an ICU stay and may be accessed as open source. Such a comparison is vital for the understanding of the relative accuracy and reliability of AI-based predictions in the context of organ failure risk compared to human performance. The data and findings from this study are anticipated to provide evidence for the clinical utility of AI-based risk scores and pave the way for future research into the optimization of AI systems for healthcare applications.
Study: NCT06814327
Study Brief:
Protocol Section: NCT06814327