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Clinical Trials/NCT05591014
NCT05591014CompletedNot Applicable

The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation

University of Utah1 site in 1 country26 target enrollmentStarted: April 13, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
26
Locations
1
Primary Endpoint
Overall Proportion of Correct Clinician Responses Pre- and Post-application

Study Overview

Brief Summary

The purpose of this study is to assess a novel rotational thromboelastometry (ROTEM®) interpretation software to determine whether its use improves the accuracy of clinician interpretation.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Current residents and attending physicians in the University of Utah Department of Anesthesiology who have a range of experience and exposure to thromboelastography

Exclusion Criteria

  • •Refusal to consent or no longer an active member of the University of Utah Department of Anesthesiology

Arms & Interventions

Software Tutorial

Experimental

Participants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software.

Intervention: Novel ROTEM interpretation software (Device)

Outcomes

Primary Outcomes

Overall Proportion of Correct Clinician Responses Pre- and Post-application

Time Frame: At pre-application (baseline) and post-application (up to 15 minutes)

Proportion of correct of clinician responses compared to a reference standard.

Overall Proportion of True Negative Clinician Responses Pre- and Post-application

Time Frame: At pre-application (baseline) and post-application (up to 15 minutes)

Proportion of correct of clinician responses compared to a reference standard.

Secondary Outcomes

  • Proportion of Correct Clinician Responses by Question Type Pre and Post Application(At pre-application (baseline) and post-application (up to 15 minutes))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alastair Moody

Assistant Professor of Anesthesiology

University of Utah

Study Sites (1)

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