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Recruiting NCT07720908

Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study

No phase Interventional Anesthesia, Epidural

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CompuFlo® CathCheck™ System Assessment.
Who it may be relevant to
Registry conditions: Anesthesia, Epidural. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessing Labor Epidural Catheter Dysfunction for Tubal Ligation in Parturients Using CompuFlo® CathCheck™ System: A Pilot Study

Overview

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.

Interventions

  • Device CompuFlo® CathCheck™ System Assessment
    Evaluation of labor epidural catheter functionality using the CompuFlo® CathCheck™ System following standard epidural test-dose administration and prior to epidural reactivation for postpartum tubal ligation.

Primary outcome measures

  • Rate of Successful Labor Epidural Catheter Reactivation [Time frame: Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)]
Secondary outcome measures (9)
  • Sensitivity of the CompuFlo® CathCheck™ System [Time frame: Pre-procedural (prior to epidural reactivation)]
  • Specificity of the CompuFlo® CathCheck™ System [Time frame: Pre-procedural (prior to epidural reactivation)]
  • Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System [Time frame: Pre-procedural (prior to epidural reactivation)]
  • Number of Dermatomal Sensory Block Levels After Epidural Test Dose [Time frame: Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)]
  • Duration of Labor Epidural Catheter Unused Time [Time frame: Periprocedural (from delivery until epidural reactivation)]
  • Frequency of Labor Epidural Top-Up Doses [Time frame: Intrapartum (from labor epidural placement until delivery)]
  • Postoperative Pain Intensity via Numeric Rating Scale (NRS-11) [Time frame: Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)]
  • Patient Satisfaction Score With Labor Analgesia [Time frame: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])]
  • Patient Satisfaction Score With Tubal Ligation Anesthesia [Time frame: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • The Ohio State University — Columbus

Identifiers

NCT: NCT07720908 · 2023H0188

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗