Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study
Purpose
This pilot study evaluates the use of the CompuFlo® CathCheck™ System to assess labor epidural catheter function before reactivation for postpartum tubal ligation. The study aims to determine whether this technology can accurately identify functional versus dysfunctional epidural catheters compared with standard clinical assessment methods. Improving catheter assessment may reduce failed epidural reactivation, the need for additional anesthesia techniques, and improve patient safety.
Condition
- Anesthesia, Epidural
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age ≥ 18 years - Postpartum women electing to undergo tubal ligation with an indwelling labor epidural catheter - Ability to provide informed consent in English - Vaginal delivery
Exclusion Criteria
- Parturients not receiving labor epidural analgesia or receiving an alternative anesthetic technique during labor and delivery - Epidural catheter located >2 cm from the documented insertion depth at initial placement - Planned elective cesarean delivery - Chronic pain conditions (e.g., chronic low back pain, sickle cell disease) - Chronic opioid use disorder - Chronic gabapentin use - Uncontrolled mood disorders that, in the investigator's judgment, may interfere with study participation or interpretation of study outcomes - Prisoners or incarcerated individuals
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- All enrolled participants will undergo the same study procedures. Following vaginal delivery and prior to postpartum tubal ligation, participants with an indwelling labor epidural catheter will receive the standard clinical epidural test dose and assessment, followed by evaluation with the CompuFlo® CathCheck™ System to detect epidural pulsatile waveform pressure. The diagnostic performance of the CompuFlo® system will be compared with the clinical reference standard for successful epidural catheter reactivation.
- Primary Purpose
- Diagnostic
- Masking
- None (Open Label)
- Masking Description
- This is an open-label study. Participants, anesthesia care providers, investigators, and outcome assessors are not masked to the CompuFlo® CathCheck™ System assessment. The device evaluation is performed as part of the study procedures, and the results are recorded prospectively. The primary outcome is based on predefined objective clinical criteria for successful labor epidural catheter reactivation, including sensory block assessment and the need for conversion to another anesthetic technique or additional anesthetic interventions.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Labor Epidural Reactivation Cohort |
Postpartum women undergoing elective tubal ligation after vaginal delivery with an indwelling labor epidural catheter. Participants will undergo standard epidural catheter assessment and reactivation, including evaluation with the CompuFlo® CathCheck™ System to determine catheter functionality and predict successful epidural anesthesia for the tubal ligation procedure. |
|
Recruiting Locations
Columbus, Ohio 43210
More Details
- Status
- Recruiting
- Sponsor
- Ohio State University
Detailed Description
Postpartum tubal ligation is a common surgical procedure performed after delivery, and labor epidural catheters are frequently used for anesthesia during this procedure. However, reactivation of labor epidural catheters after vaginal delivery can fail, requiring conversion to spinal or general anesthesia. Reported failure rates are significant, and factors such as prolonged time since delivery, prior need for additional epidural medication during labor, and poor analgesic satisfaction may increase the risk of failure. Currently, there is no standardized method to confirm the continued function and location of an epidural catheter after childbirth and before reactivation for postpartum procedures. Standard clinical practice typically relies on catheter aspiration, epidural test dosing, and assessment of sensory blockade, but these methods may not reliably identify catheter dysfunction or migration. This prospective pilot cohort study will evaluate the use of the CompuFlo® CathCheck™ System as an additional objective tool for assessing labor epidural catheter function before postpartum tubal ligation. The system uses computerized pressure measurements and pulsatile waveform detection to evaluate epidural catheter placement and patency. Study assessments will be compared with standard clinical evaluation methods to determine the ability of the device to identify functional versus dysfunctional epidural catheters. The primary objective of this study is to assess the diagnostic accuracy of the CompuFlo® CathCheck™ System, including its sensitivity and specificity, in predicting successful epidural catheter reactivation. This study aims to determine whether incorporating objective pressure and waveform measurements can improve identification of catheter dysfunction, reduce failed epidural reactivation, minimize the need for additional anesthesia procedures, and enhance patient safety during postpartum tubal ligation.