Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study
Assessing Labor Epidural Catheter Dysfunction for Tubal Ligation in Parturients Using CompuFlo® CathCheck™ System: A Pilot Study
Обзор исследования
Статус
Условия
Вмешательство/лечение
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Ling-Qun Hu, MD
- Номер телефона: 6142933559
- Электронная почта: lingqun.hu@osumc.edu
Учебное резервное копирование контактов
- Имя: Alberto Uribe Vega
- Номер телефона: 6142933559
- Электронная почта: alberto.uribe@osumc.edu
Места учебы
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Ohio
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Columbus, Ohio, Соединенные Штаты, 43210
- Рекрутинг
- The Ohio State University
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Диагностика
- Распределение: Н/Д
- Интервенционная модель: Одногрупповое задание
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Rate of Successful Labor Epidural Catheter Reactivation
Временное ограничение: Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)
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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).
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Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Sensitivity of the CompuFlo® CathCheck™ System
Временное ограничение: Pre-procedural (prior to epidural reactivation)
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The sensitivity percentage of the CompuFlo® CathCheck™ System for correctly identifying functional labor epidural catheters that successfully provide anesthesia for postpartum tubal ligation.
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Pre-procedural (prior to epidural reactivation)
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Specificity of the CompuFlo® CathCheck™ System
Временное ограничение: Pre-procedural (prior to epidural reactivation)
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The specificity percentage of the CompuFlo® CathCheck™ System for correctly identifying non-functional labor epidural catheters.
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Pre-procedural (prior to epidural reactivation)
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Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System
Временное ограничение: Pre-procedural (prior to epidural reactivation)
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The AUC value of the CompuFlo® CathCheck™ System to evaluate its overall diagnostic performance in discriminating between functional and non-functional labor epidural catheters.
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Pre-procedural (prior to epidural reactivation)
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Number of Dermatomal Sensory Block Levels After Epidural Test Dose
Временное ограничение: Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)
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The number of dermatomal levels demonstrating loss of cold sensation following a standard epidural local anesthetic test dose.
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Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)
|
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Duration of Labor Epidural Catheter Unused Time
Временное ограничение: Periprocedural (from delivery until epidural reactivation)
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The total duration of time (measured in hours) between the completion of labor analgesia and the attempted epidural reactivation for the tubal ligation.
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Periprocedural (from delivery until epidural reactivation)
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Frequency of Labor Epidural Top-Up Doses
Временное ограничение: Intrapartum (from labor epidural placement until delivery)
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The total number of supplemental epidural local anesthetic bolus doses administered during labor prior to delivery.
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Intrapartum (from labor epidural placement until delivery)
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Postoperative Pain Intensity via Numeric Rating Scale (NRS-11)
Временное ограничение: Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)
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Pain intensity measured using the 11-point Numeric Rating Scale (NRS-11), where 0 represents "no pain" and 10 represents "the worst pain imaginable."
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Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)
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Patient Satisfaction Score With Labor Analgesia
Временное ограничение: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
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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").
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Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
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Patient Satisfaction Score With Tubal Ligation Anesthesia
Временное ограничение: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
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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").
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Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
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Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2023H0188
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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