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

NCT07025096 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2026-02-17

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Gary Weissman, MD, MSHP · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-12-05
Primary Completion
2026-05-31
Completion
2026-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07025096 on ClinicalTrials.gov