CompuFlo CathCheck

University of Minnesota (UMN)

Status and phase: Enrolling; Phase 4

Conditions: Epidural Placement

Treatments: Device: 3 methods intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06460155

ANES-2024-32648

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Experimental group

Experimental group

Treatment:

Device: 3 methods intervention