Back to resultsThe Effectiveness of a Novel Software Program to Help in ROTEM Interpretation
Primary Purpose
Coagulation Disorder, Blood
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novel ROTEM interpretation software
Sponsored by
About this trial
This is an interventional diagnostic trial for Coagulation Disorder, Blood
Eligibility Criteria
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.
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Sites / Locations
- University of UtahRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Software Tutorial
Arm Description
Participants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software.
Outcomes
Primary Outcome Measures
Diagnostic accuracy
sensitivity/specificity of clinician responses compared to a reference standard
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05591014
Brief Title
The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation
Official Title
The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 13, 2023 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Utah
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coagulation Disorder, Blood
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The sensitivity/specificity and diagnostic accuracy of clinicians will be compared before and after the use of novel ROTEM app. The performance of more experienced clinicians will be compared to those with little to no experience in ROTEM. Analysis will be done using a mixed effects model to account for clustering of measurements within clinician groups. Inter-rater reliability analysis will be done to assess the similarity within clinician groups using the ICC.
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Software Tutorial
Arm Type
Experimental
Arm Description
Participants will be asked to interpret a series of ROTEM studies before and after a tutorial on a novel ROTEM interpretation software.
Intervention Type
Device
Intervention Name(s)
Novel ROTEM interpretation software
Intervention Description
Clinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software.
Primary Outcome Measure Information:
Title
Diagnostic accuracy
Description
sensitivity/specificity of clinician responses compared to a reference standard
Time Frame
1 year of data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Silverton, MD
Phone
8015816393
Email
natalie.silverton@hsc.utah.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jacob Steenblik
Phone
8015811216
Email
jacob.steenblik@hsc.utah.edu
Facility Information:
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalie Silverton, MD
Phone
801-581-6393
Email
natalie.silverton@hsc.utah.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effectiveness of a Novel Software Program to Help in ROTEM Interpretation
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