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

17 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

120

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Ling-Qun Hu, MD
  • Número de teléfono: 6142933559
  • Correo electrónico: lingqun.hu@osumc.edu

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Estados Unidos
    • Ohio
      • Columbus, Ohio, Estados Unidos, 43210
        • Reclutamiento
        • The Ohio State University

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Diagnóstico
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
Dispositivo: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Rate of Successful Labor Epidural Catheter Reactivation
Periodo de tiempo: 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)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Sensitivity of the CompuFlo® CathCheck™ System
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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])

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ohio State University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de diciembre de 2024

Finalización primaria (Estimado)

31 de octubre de 2028

Finalización del estudio (Estimado)

31 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

17 de julio de 2026

Publicado por primera vez (Actual)

22 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Otros números de identificación del estudio

  • 2023H0188

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

Sí

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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