Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study
Start Date
12/19/2024
Completion Date
12/31/2028
Summary
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.
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
CompuFlo® CathCheck™ System Assessment
Conditions
Locations
The Ohio State University
Columbus, Ohio 43210
United States