Assessing Labor Epidural Catheter Dysfunction for Tubal Ligation in Parturients Using CompuFlo® CathCheck™ System: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Rate of Successful Labor Epidural Catheter Reactivation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Rate of Successful Labor Epidural Catheter Reactivation
时间窗: 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).
次要结局
- Sensitivity of the CompuFlo® CathCheck™ System(Pre-procedural (prior to epidural reactivation))
- Specificity of the CompuFlo® CathCheck™ System(Pre-procedural (prior to epidural reactivation))
- Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System(Pre-procedural (prior to epidural reactivation))
- Number of Dermatomal Sensory Block Levels After Epidural Test Dose(Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation))
- Duration of Labor Epidural Catheter Unused Time(Periprocedural (from delivery until epidural reactivation))
- Frequency of Labor Epidural Top-Up Doses(Intrapartum (from labor epidural placement until delivery))
- Postoperative Pain Intensity via Numeric Rating Scale (NRS-11)(Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU))
- Patient Satisfaction Score With Labor Analgesia(Periprocedural (prior to discharge from the post-anesthesia care unit [PACU]))
- Patient Satisfaction Score With Tubal Ligation Anesthesia(Periprocedural (prior to discharge from the post-anesthesia care unit [PACU]))
研究者
Ling-Qun Hu
Clinical Professor
Ohio State University