Coagulation Disorder, Blood
Conditions
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.
Interventions
DEVICENovel ROTEM interpretation software
Clinicians will be asked to interpret ROTEM studies before and after exposure to a novel ROTEM interpretation software.
Sponsors
University of Utah
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Proportion of Correct Clinician Responses Pre- and Post-application | 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 | At pre-application (baseline) and post-application (up to 15 minutes) | Proportion of correct of clinician responses compared to a reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Correct Clinician Responses by Question Type Pre and Post Application | At pre-application (baseline) and post-application (up to 15 minutes) | Proportion of correct responses with 95% confidence intervals for cryoprecipitate, fresh frozen plasma, multiple-product scenarios, normal patterns, and platelets, shown separately for pre- and post-application |
Countries
United States
Baseline characteristics
| Characteristic | — |
|---|---|
| Mean proportion of correct responses by question type, pre-test Cryoprecipitate | 0.11 proportion of true positives |
| Mean proportion of correct responses by question type, pre-test Fresh Frozen Plasma | 0.25 proportion of true positives |
| Mean proportion of correct responses by question type, pre-test Multiple-Product Scenarios | 0.18 proportion of true positives |
| Mean proportion of correct responses by question type, pre-test Normal Patterns | 0.49 proportion of true positives |
| Mean proportion of correct responses by question type, pre-test Platelet | 0.56 proportion of true positives |
| Overall mean of correct responses, pre-test | 0.364549 proportion of correct responses |
| Overall mean of true negatives, pre-test | 0.88 proportion of negative responses |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed