CompuFlo CathCheck for Epidurals
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the CompuFlo CathCheck treatment?
The research on computer-integrated patient-controlled epidural analgesia (CIPCEA) shows that systems which automatically adjust drug delivery based on individual needs can effectively manage pain during labor, suggesting that similar technology in the CompuFlo CathCheck treatment may also be effective in providing personalized pain relief.12345
Is the CompuFlo CathCheck system safe for use in humans?
The CompuFlo system has been used in several studies to help identify the epidural space, showing promising results in reducing complications like postdural puncture headache. However, there have been instances of false negatives, suggesting that while it may improve safety, it should be used by experienced practitioners.678910
How does the CompuFlo CathCheck treatment differ from other treatments for epidurals?
Research Team
Aaron Berg
Principal Investigator
University of Minnesota
Eligibility Criteria
This trial is for adults aged 18-99 who are having an epidural placed for surgery. It's not suitable for those outside this age range or not undergoing the procedure.Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo procedures to determine epidural catheter location using Compuflo CathCheck and epidurogram
Follow-up
Participants are monitored for safety and effectiveness after the procedure
Treatment Details
Interventions
- CompuFlo CathCheck
CompuFlo CathCheck is already approved in United States for the following indications:
- Verification of epidural needle placement in the lumbar or thoracic epidural space
- Confirmation of epidural catheter location
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor