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NCT Number: NCT06460155

CompuFlo CathCheck

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.

Recruiting

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Key information

Conditions

Epidural Placement

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location status: Recruiting

Location contact

Candace Nelson

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 methods intervention

Device

Stu All participants will undergo all three methods being studied: epidurogram (gold standard), CompuFlo CathCheck, and physical exam in PACU following epidural placement.

Primary outcomes

  1. CompuFlo's Success

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Candace Nelson

CONTACT

[email protected]

Kristine Kancans

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 14, 2024
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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