Epidural Placement
Conditions
Keywords
Epidural
Brief summary
The purpose of this study is to determine if the Compuflo CathCheck system is equivalent to an epidurogram in determining epidural catheter location (in or outside the epidural space), using the epidurogram as the gold standard. In short, this will be completed by performing an epidurogram (as is standard of practice and the gold standard of determining epidural placement) and compare it to the results of the Compuflo CathCheck system. Equivalency will be summarized through agreement and concordance. Additionally, secondary outcomes will look at how classical physical exam findings to confirm epidural placement correlate and compare to epidurogram and Compuflo CathCheck findings.
Interventions
DEVICE3 methods intervention
Stu All participants will undergo all three methods being studied: epidurogram (gold standard), CompuFlo CathCheck, and physical exam in PACU following epidural placement.
Sponsors
University of Minnesota
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
This study is a prospective diagnostic accuracy study. All participants will undergo all three methods being studied: epidurogram (gold standard), CompuFlo CathCheck, and physical exam in PACU following epidural placement.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Any adult patients (age 18-99 years old) undergoing epidural placement for an operative procedure will be eligible for participation in this study.
Exclusion criteria
* All patients unable to receive or who refuse placement of epidural will be excluded * patients who are unable to consent * non-English speakers, pregnant individuals) * Individuals with known or who have an allergic reaction to bupivacaine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CompuFlo's Success | baseline | The measure is a binary outcome: the epidural catheter is in the epidural space or not. Each modality assessed will either conclude positive (in the correct space) no negative (notnint he correct space) There is no value. The tools used for the assessment is actually what is being studied, compuflo, meniscus test, physical exam and epidurogram. |
Countries
United States
Contacts
Primary ContactCandace Nelson
Backup ContactKristine Kancans
Outcome results
None listed