50 Participants Needed

CompuFlo CathCheck for Epidurals

CN
KK
Overseen ByKristine Kancans
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of Minnesota
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 1 JurisdictionThis treatment is already approved in other countries

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?

The CompuFlo CathCheck treatment is unique because it uses a computerized system to provide real-time pressure feedback, helping to accurately identify the epidural space, which can reduce complications and improve the success rate compared to the traditional, more subjective methods.678910

Research Team

AB

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

2-4 weeks

Treatment

Participants undergo procedures to determine epidural catheter location using Compuflo CathCheck and epidurogram

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

Treatment Details

Interventions

  • CompuFlo CathCheck
Trial Overview The study tests if the CompuFlo CathCheck system can accurately locate epidural catheters, comparing it to the gold standard, which is an epidurogram. The results from both methods will be compared to see if they agree.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Experimental groupExperimental Treatment1 Intervention

CompuFlo CathCheck is already approved in United States for the following indications:

🇺🇸
Approved in United States as CompuFlo CathCheck System for:
  • 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

Trials
1,459
Recruited
1,623,000+

Findings from Research

In a study of 280 nulliparous women using a computer-integrated patient-controlled epidural analgesia (CIPCEA) system, the incidence of breakthrough pain during labor was found to be 9.6%.
Key factors associated with breakthrough pain included dysfunctional labor, higher maternal body mass index, and a low successful-to-total-bolus-demand ratio, which also correlated with decreased maternal satisfaction and increased local anesthetic consumption.
Incidence and characteristics of breakthrough pain in parturients using computer-integrated patient-controlled epidural analgesia.Sng, BL., Zhang, Q., Leong, WL., et al.[2022]
The Go Medical epidural infuser provided effective pain control for 20 patients after elective Caesarean sections, allowing them to manage their own pain relief and maintain good mobility.
Patients reported high satisfaction with the device, and all indicated they would use it again, highlighting its safety and efficacy in a postnatal ward setting despite occasional equipment failures.
A portable, disposable device for patient-controlled epidural analgesia following Caesarean section: evaluation by patients and nurses.Banks, S., Pavy, T.[2019]
Epidural analgesia (EA) techniques, including continuous and patient-controlled methods, provide modest pain relief at rest compared to intravenous patient-controlled analgesia (IVPCA) after intra-abdominal surgery, with a mean pain reduction of 5.7 points within the first 6 hours and 9.0 points from 7 to 24 hours, based on a review of 32 studies involving 1716 participants.
While EA may offer some benefits in pain management, it is associated with a higher risk of complications such as failure of the analgesic technique, hypotension requiring intervention, and pruritus, indicating that the choice of analgesia should consider both efficacy and safety.
Epidural analgesia versus patient-controlled intravenous analgesia for pain following intra-abdominal surgery in adults.Salicath, JH., Yeoh, EC., Bennett, MH.[2021]

References

Incidence and characteristics of breakthrough pain in parturients using computer-integrated patient-controlled epidural analgesia. [2022]
A portable, disposable device for patient-controlled epidural analgesia following Caesarean section: evaluation by patients and nurses. [2019]
Epidural analgesia versus patient-controlled intravenous analgesia for pain following intra-abdominal surgery in adults. [2021]
Comparison of computer-integrated patient-controlled epidural analgesia with no initial basal infusion versus moderate basal infusion for labor and delivery: A randomized controlled trial. [2020]
[Continuous epidural perfusion with meperidine on demand for the treatment of postoperative pain]. [2013]
Epidural Needle Extension through the Ligamentum Flavum Using the Standard versus the CompuFlo®-Assisted Loss of Resistance to Saline Technique: A Simulation Study. [2022]
Experimental validation of the CompuFlo® epidural controlled system to identify the epidural space and its clinical use in difficult obstetric cases. [2022]
Differentiating False Loss of Resistance from True Loss of Resistance While Performing the Epidural Block with the CompuFlo® Epidural Instrument. [2022]
[Identification of the epidural space using pressure waveform analysis (CompuFlo® technology): a case series]. [2021]
Pressure monitoring devices may undetect epidural space: a report on the use of Compuflo® system for epidural injection. [2023]
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