CompuFlo CathCheck for Epidurals

Overseen By Kristine Kancans

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Minnesota

Disqualifiers: Non-English speakers, Pregnant, Bupivacaine allergy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called CompuFlo CathCheck to determine if it accurately identifies the position of an epidural catheter, crucial for procedures using epidurals (a type of pain relief injection). The goal is to assess whether this system is as reliable as the current standard method, the epidurogram. Researchers will also compare physical exam findings with results from both the CompuFlo CathCheck and the epidurogram. Adults undergoing surgery with an epidural may be suitable candidates for this trial. As a Phase 4 trial, this research involves an FDA-approved system and aims to enhance understanding of its benefits for more patients.

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 is the safety track record for the CompuFlo CathCheck system?

Research has shown that the CompuFlo CathCheck system is safe for people. Studies indicate that this system matches the safety and effectiveness of traditional methods for epidural procedures. The FDA in the United States has approved it, and it has received the CE mark in the European Union, confirming it meets safety standards in these regions.

The CompuFlo device ensures correct epidural placement by detecting pressure changes, which can reduce risks and improve accuracy during the procedure. Both lab and clinical tests have demonstrated that the CompuFlo system is as safe as traditional epidural methods.

In summary, the CompuFlo CathCheck system is well-tolerated, with no major safety concerns reported in studies. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the CompuFlo CathCheck system because it offers a novel way to improve the safety and accuracy of epidural procedures. Unlike traditional methods, which often rely on subjective assessments by healthcare providers, the CompuFlo CathCheck uses objective pressure-sensing technology to confirm the correct placement of the epidural needle. This real-time feedback could reduce the risk of complications and enhance patient comfort by ensuring more precise administration. By potentially streamlining the epidural process, this technology could significantly improve patient outcomes and healthcare efficiency.

What evidence suggests that the CompuFlo CathCheck system is effective for determining epidural catheter location?

Research has shown that the CompuFlo CathCheck system, used by participants in this trial, accurately finds the epidural space by measuring real-time pressure changes. This system ensures correct epidural needle placement, crucial for safe and effective pain relief. In past studies, the device successfully detected the loss of resistance, a key indicator of correct needle placement. This method reduces risks by offering a clear and quick way to verify needle placement. Multiple studies support the system's ability to confirm epidural placement, suggesting it may be a reliable tool for doctors. ^{1 2 3 6 7}

Who Is on the Research Team?

Aaron Berg

Principal Investigator

University of Minnesota

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Experimental group Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Minnesota

Lead Sponsor

Trials

1,459

Recruited

1,623,000+

Published Research Related to This Trial

The Compuflo® computerized injection pump can assist in lumbar epidural infiltration by providing real-time pressure monitoring, potentially improving the accuracy of needle placement in chronic pain management.

However, in a study of 60 procedures, there was a 10% false negative rate where the device failed to indicate proper epidural space entry, suggesting that while it can be helpful, it should only be used by experienced practitioners until further investigations clarify its reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pressure monitoring devices may undetect epidural space: a report on the use of Compuflo® system for epidural injection. Carassiti, M., Pascarella, G., Strumia, A., et al.[2023]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural analgesia versus patient-controlled intravenous analgesia for pain following intra-abdominal surgery in adults. Salicath, JH., Yeoh, EC., Bennett, MH.[2021]

The CompuFlo® epidural instrument demonstrated a high sensitivity (0.83) and specificity in distinguishing true loss of resistance from false loss of resistance during epidural procedures, based on a study involving 120 healthy women.

Using CompuFlo® can significantly improve the accuracy of epidural space identification, potentially reducing the number of failed attempts and the risk of complications like accidental dural puncture, especially in challenging cases or for less experienced practitioners.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differentiating False Loss of Resistance from True Loss of Resistance While Performing the Epidural Block with the CompuFlo® Epidural Instrument. Vaira, P., Camorcia, M., Palladino, T., et al.[2022]

In a series of 24 epidural procedures using the CompuFlo® technology, the epidural space was successfully identified in 23 cases, demonstrating its high efficacy in clinical practice.

The CompuFlo® device provides objective feedback through pressure curves and acoustic signals, which may help reduce complications associated with traditional techniques, such as postdural puncture headaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Identification of the epidural space using pressure waveform analysis (CompuFlo® technology): a case series]. Helf, A., Schlesinger, T., Roewer, N., et al.[2021]

In a study of 76 parturients, the computer-integrated patient-controlled epidural analgesia (CIPCEA) system showed similar local anesthetic consumption between two groups: one with no initial basal infusion and another with a moderate basal infusion of 5 ml/H, suggesting that the initial infusion may not be necessary.

Both groups experienced comparable levels of breakthrough pain, delivery modes, and patient satisfaction, indicating that CIPCEA can effectively manage pain during labor without significantly impacting fetal outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Sng, BL., Woo, D., Leong, WL., et al.[2020]

The CompuFlo® device was validated as an effective tool for identifying the epidural space during labor epidural analgesia, showing a strong correlation between the pressure readings and the anesthesiologist's sensations (Rho = 0.79).

In cases where trainees faced difficulties with epidural placement, the use of CompuFlo® led to successful epidural analgesia on the first attempt, indicating its potential as a reliable rescue tool in challenging situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experimental validation of the CompuFlo® epidural controlled system to identify the epidural space and its clinical use in difficult obstetric cases. Capogna, G., Camorcia, M., Coccoluto, A., et al.[2022]

Epidural administration of meperidine through a patient-controlled analgesia (PCA) system provided effective postoperative pain relief for patients undergoing high abdominal surgery, with no significant side effects reported.

Patients using epidural meperidine required less additional analgesia compared to those receiving subcutaneous meperidine, indicating higher satisfaction and better pain management with the epidural method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Continuous epidural perfusion with meperidine on demand for the treatment of postoperative pain]. Balust, J., Boada, J., Taurà, P., et al.[2013]

In a study involving 52 expert anesthesiologists, the CompuFlo® epidural system significantly reduced the needle extension length to just 0.68 mm compared to 3.90 mm with the traditional loss of resistance technique, indicating a more precise identification of the epidural space.

The use of CompuFlo® resulted in less variability in needle placement, making it a more predictable and effective tool for anesthesiologists during epidural procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Epidural Needle Extension through the Ligamentum Flavum Using the Standard versus the CompuFlo®-Assisted Loss of Resistance to Saline Technique: A Simulation Study. Capogna, E., Coccoluto, A., Velardo, M.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and characteristics of breakthrough pain in parturients using computer-integrated patient-controlled epidural analgesia. Sng, BL., Zhang, Q., Leong, WL., et al.[2022]

Citations

1. milestonescientific.com milestonescientific.com/medical-solutions/compuflo-epidural

CompuFlo Epidural System: Reduce Risks & Improve ... The CompuFlo instrument offers objective detection of pressure changes to verify true loss of resistance and confirm epidural space within minutes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04240912

Epidural Pressure Waveform Recordings by the CompuFlo ... The CompuFlo Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables ...

3. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K221702.pdf

February 25, 2023 Milestone Scientific, Inc. Kevin Go ... The CompuFlo® Epidural Computer Control Anesthesia System is intended for use with an epidural needle for the real-time verification of needle ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9637600/

a report on the use of Compuflo® system for epidural ... Pressure monitoring devices may undetect epidural space: a report on the use of Compuflo® system for epidural injection.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2352556825000621

Objective real-time epidural pressure measurement using ... The CompuFlo® device allowed a pressure measurement prior to obtaining LOR during EA catheter placement in children. Younger children appear to have lower ...

6. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf16/K161883.pdf

Milestone Scientific, Inc. Stephen Solomon Director ... Based on the nonclinical and clinical tests conducted, it was demonstrated that the CompuFlo. Epidural device is as safe, as effective and ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6038690/

Objective Evaluation of a New Epidural Simulator by the ... The aim of the study was to validate and evaluate the realism of our device by using a Computerized Epidural Instrument (CompuFlo) [4]. 2.