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

2026年7月17日 更新者：Ling-Qun Hu、Ohio State University

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

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.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

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.

研究类型

介入性

注册 (估计的)

120

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 美国
    • Ohio
      • Columbus、Ohio、美国、43210
        • 招聘中
        • The Ohio State University

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：诊断
  • 分配：不适用
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：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.
设备：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.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Rate of Successful Labor Epidural Catheter Reactivation
大体时间：Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)
The percentage of participants with successful use of the existing labor epidural catheter for postpartum tubal ligation without evidence of catheter failure or the need for alternative anesthesia techniques (e.g., conversion to general anesthesia or spinal anesthesia).
Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)

次要结果测量

结果测量
措施说明
大体时间
Sensitivity of the CompuFlo® CathCheck™ System
大体时间：Pre-procedural (prior to epidural reactivation)
The sensitivity percentage of the CompuFlo® CathCheck™ System for correctly identifying functional labor epidural catheters that successfully provide anesthesia for postpartum tubal ligation.
Pre-procedural (prior to epidural reactivation)
Specificity of the CompuFlo® CathCheck™ System
大体时间：Pre-procedural (prior to epidural reactivation)
The specificity percentage of the CompuFlo® CathCheck™ System for correctly identifying non-functional labor epidural catheters.
Pre-procedural (prior to epidural reactivation)
Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System
大体时间：Pre-procedural (prior to epidural reactivation)
The AUC value of the CompuFlo® CathCheck™ System to evaluate its overall diagnostic performance in discriminating between functional and non-functional labor epidural catheters.
Pre-procedural (prior to epidural reactivation)
Number of Dermatomal Sensory Block Levels After Epidural Test Dose
大体时间：Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)
The number of dermatomal levels demonstrating loss of cold sensation following a standard epidural local anesthetic test dose.
Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)
Duration of Labor Epidural Catheter Unused Time
大体时间：Periprocedural (from delivery until epidural reactivation)
The total duration of time (measured in hours) between the completion of labor analgesia and the attempted epidural reactivation for the tubal ligation.
Periprocedural (from delivery until epidural reactivation)
Frequency of Labor Epidural Top-Up Doses
大体时间：Intrapartum (from labor epidural placement until delivery)
The total number of supplemental epidural local anesthetic bolus doses administered during labor prior to delivery.
Intrapartum (from labor epidural placement until delivery)
Postoperative Pain Intensity via Numeric Rating Scale (NRS-11)
大体时间：Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)
Pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), where 0 represents "no pain" and 10 represents "the worst pain imaginable."
Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)
Patient Satisfaction Score With Labor Analgesia
大体时间：Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
Patient-reported satisfaction with labor epidural analgesia, assessed using a standard Likert scale (e.g., 1-5 scale, where 1 is "highly dissatisfied" and 5 is "highly satisfied").
Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
Patient Satisfaction Score With Tubal Ligation Anesthesia
大体时间：Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
Patient-reported satisfaction with anesthetic management during the postpartum tubal ligation procedure, assessed using a standard Likert scale (e.g., 1-5 scale, where 1 is "highly dissatisfied" and 5 is "highly satisfied").
Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Ohio State University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年12月19日

初级完成 (估计的)

2028年10月31日

研究完成 (估计的)

2028年12月31日

研究注册日期

首次提交

2026年7月13日

首先提交符合 QC 标准的

2026年7月17日

首次发布 (实际的)

2026年7月22日

研究记录更新

最后更新发布 (实际的)

2026年7月22日

上次提交的符合 QC 标准的更新

2026年7月17日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2023H0188

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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