Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: CompuFlo® CathCheck™ System Assessment.
- Кому может быть актуально
- Состояния в реестре: Anesthesia, Epidural. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Assessing Labor Epidural Catheter Dysfunction for Tubal Ligation in Parturients Using CompuFlo® CathCheck™ System: A Pilot Study
Обзор
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.
Подробное описание
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.
Вмешательства
- Устройство 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.
Первичные конечные точки
- Rate of Successful Labor Epidural Catheter Reactivation [Срок оценки: Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)]
Вторичные конечные точки (9)
- Sensitivity of the CompuFlo® CathCheck™ System [Срок оценки: Pre-procedural (prior to epidural reactivation)]
- Specificity of the CompuFlo® CathCheck™ System [Срок оценки: Pre-procedural (prior to epidural reactivation)]
- Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System [Срок оценки: Pre-procedural (prior to epidural reactivation)]
- Number of Dermatomal Sensory Block Levels After Epidural Test Dose [Срок оценки: Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)]
- Duration of Labor Epidural Catheter Unused Time [Срок оценки: Periprocedural (from delivery until epidural reactivation)]
- Frequency of Labor Epidural Top-Up Doses [Срок оценки: Intrapartum (from labor epidural placement until delivery)]
- Postoperative Pain Intensity via Numeric Rating Scale (NRS-11) [Срок оценки: Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)]
- Patient Satisfaction Score With Labor Analgesia [Срок оценки: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])]
- Patient Satisfaction Score With Tubal Ligation Anesthesia [Срок оценки: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Диагностика
Центры проведения
США · 1 центр
- The Ohio State University — Columbus
Идентификаторы
NCT: NCT07720908 · 2023H0188