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Recruiting NCT06460155

CompuFlo CathCheck

Phase IV Interventional Epidural Placement

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3 methods intervention.
Who it may be relevant to
Registry conditions: Epidural Placement. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

  • Device 3 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.

Primary outcome measures

  • CompuFlo's Success [Time frame: baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • University of Minnesota — Minneapolis

Identifiers

NCT: NCT06460155 · ANES-2024-32648

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗