BACKGROUND: Artificial intelligence (AI) and computerized clinical decision support systems (CDSS) are increasingly applied in intensive care, yet their clinical impact remains uncertain, as most studies focus on model development rather than prospective evaluation.
OBJECTIVES: To identify randomized controlled trials (RCTs) evaluating AI-based or CDSS interventions intended to influence real-time decision-making in adult intensive care units (ICUs) and to assess their effects on process and patient-centered outcomes.
METHODS: We conducted a systematic review of randomized controlled trials (RCTs). PubMed, Embase, Cochrane CENTRAL, ScienceDirect, and IEEE Xplore were searched from inception to November 2025. Eligible studies evaluated AI-based or CDSS interventions in adult ICU patients. Study quality was assessed using RoB 2 and CONSORT-AI criteria.
RESULTS: Ten RCTs were included, enrolling approximately 100,000 adult ICU patients. Five trials evaluated AI-based interventions and five evaluated CDSS. Eight trials showed improvements in at least one process measure, including earlier recognition of deterioration, improved protocol adherence, and physiological stability. However, patient-centered benefits were uncommon. Two trials reported reductions in mortality (a sepsis prediction model and a machine-learning-based early-warning system), while most studies showed no consistent effects on clinical outcomes. Reporting of AI-specific elements-dataset provenance, algorithm versioning, and human-AI interaction-was frequently incomplete.
CONCLUSIONS: AI and CDSS interventions in adult ICUs are associated with improvements in process-related outcomes but show limited and inconsistent effects on patient-centered endpoints. These findings highlight a persistent gap between algorithmic innovation and clinical validation and underscore the need for pragmatic randomized trials with improved reporting and integration into clinical workflows.
| Discipline Area | Score |
|---|---|
| Physician |  |
, McMaster University