NCT07025096

Evaluating Artificial Intelligence-Based Clinical Decision Support for Sepsis and ARDS

Evaluating Artificial Intelligence-Based Comprehensive Clinical Decision Support for Sepsis and ARDS

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 350 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Sepsis and acute respiratory distress syndrome (ARDS) are common in intensive care units. Managing sepsis and ARDS is inherently complex and requires making numerous decisions under uncertainty. Artificial intelligence (AI) clinical decision support systems (CDSSs) offer a promising approach to support care management for sepsis and ARDS. The goal of this randomized, survey-based study is to compare treatment recommendations enacted by clinicians to those generated by an AI CDSS. The study will investigate whether an AI CDSS can generate treatment recommendations that are safe, appropriate, and indistinguishable to those provided by real clinicians. In this study, participants (i.e., critical care clinicians) will review a series of critical care cases (vignettes) in an electronic survey. Each vignette will contain a de-identified case of a patient with sepsis and ARDS as well as treatment recommendations for the case. Participants will assess the safety and appropriateness of each treatment recommendations and answer whether they think the treatment recommendations came from the clinician or an AI CDSS.

Conditions

• Sepsis
• Acute Respiratory Distress Syndrome (ARDS)

Interventions

Type	Name	Description
OTHER	Artifical Intelligence-Generated Treatment Recommendations	The clinical vignette will contain treatment recommendations which were generated by an artificial intelligence-based clinical decision support system.

Timeline

• Start date: 2025-12-05
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-06-17
• Last updated: 2026-02-17

Locations

1 site across 1 country: United States