RecruitingPhase 4NCT06460155

CompuFlo CathCheck

CompuFlo CathCheck; Using Pulse Wave Analysis Versus the Epidurogram for Determining Epidural Catheter Location, A Crossover Study


Sponsor

University of Minnesota

Enrollment

50 participants

Start Date

Sep 30, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria1

  • Any adult patients (age 18-99 years old) undergoing epidural placement for an operative procedure will be eligible for participation in this study.

Exclusion Criteria4

  • 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

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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.


Locations(1)

University of Minnesota

Minneapolis, Minnesota, United States

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NCT06460155