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Active Not RecruitingNCT06814327

Assessment of Organ Failure Risk Predictions in ICU

Prospective Assessment of Risk Predictions of Organ Failure in the Intensive Care Unit - Comparing Accuracy of Human and AI Risk Predictions

Status
Active Not Recruiting
Phase
Study type
Observational
Enrollment
499 (actual)
Sponsor
ETH Zurich · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Timeline

Start date
2024-11-18
Primary completion
2025-05-15
Completion
2026-05-15
First posted
2025-02-07
Last updated
2025-08-28

Locations

1 site across 1 country: Switzerland

Source: ClinicalTrials.gov record NCT06814327. Inclusion in this directory is not an endorsement.