Evaluating the Compuflo CathCheck system for epidural catheter placement
CompuFlo CathCheck; Using Pulse Wave Analysis Versus the Epidurogram for Determining Epidural Catheter Location, A Crossover Study
This study is testing if the Compuflo CathCheck system can accurately find the right spot for epidural catheters, compared to the traditional method, to see if it can be used instead.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Minnesota Academic / other |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT06460155 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of the Compuflo CathCheck system in determining the correct location of epidural catheters compared to the traditional epidurogram, which is considered the gold standard. Participants will undergo both an epidurogram and the Compuflo CathCheck assessment to evaluate their concordance and agreement. Additionally, the study will explore how traditional physical exam findings correlate with the results from both methods. The goal is to establish whether the Compuflo system can reliably replace the epidurogram in clinical practice.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients aged 18 to 99 who are scheduled to undergo epidural placement for an operative procedure.
Not a fit: Patients who are unable to consent, refuse epidural placement, or have specific allergies or conditions that preclude them from receiving an epidural will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more efficient and less invasive method for confirming epidural catheter placement, improving patient safety and comfort.
How similar studies have performed: While the Compuflo CathCheck system is a novel approach, similar studies evaluating alternative methods for confirming epidural placement have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Minneapolis, Minnesota
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Aaron Berg — University of Minnesota
- Study coordinator: Candace Nelson
- Email: nelso377@umn.edu
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.