CompuFlo CathCheck

Epidural Placement Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06460155
• Other study ID #: ANES-2024-32648
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 3, 2024
• Est. completion date: March 31, 2027

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: Candace Nelson
• Email: nelso377[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 31, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Epidural Placement

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CompuFlo's Success	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.	baseline