[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07720908":3,"trial-entities:NCT07720908":123,"trial-summary:NCT07720908":128},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":39,"secondary_outcomes":44,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":98,"locations":101,"central_contacts":111,"overall_officials":120,"references":121,"see_also_links":122},"NCT07720908","2023H0188","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","RECRUITING","2028-12-31","2026-07","2026-07-22","2024-12-19","Ohio State University","OTHER",true,"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.","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.\n\nCurrently, 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.\n\nThis 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.\n\nThe 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.",[19],"Anesthesia, Epidural",[21,22,23,24],"Labor epidural catheter","Epidural catheter dysfunction","CompuFlo CathCheck System","Tubal ligation in parturients","INTERVENTIONAL","DIAGNOSTIC",[28],"NA",{"count":30,"type":31},120,"ESTIMATED",[33],{"type":34,"name":35,"description":36,"armGroupLabels":37},"DEVICE","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.",[38],"Labor Epidural Reactivation Cohort",[40],{"measure":41,"description":42,"timeFrame":43},"Rate of Successful Labor Epidural Catheter Reactivation","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)",[45,49,52,55,59,63,67,71,75],{"measure":46,"description":47,"timeFrame":48},"Sensitivity of the CompuFlo® CathCheck™ System","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)",{"measure":50,"description":51,"timeFrame":48},"Specificity of the CompuFlo® CathCheck™ System","The specificity percentage of the CompuFlo® CathCheck™ System for correctly identifying non-functional labor epidural catheters.",{"measure":53,"description":54,"timeFrame":48},"Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System","The AUC value of the CompuFlo® CathCheck™ System to evaluate its overall diagnostic performance in discriminating between functional and non-functional labor epidural catheters.",{"measure":56,"description":57,"timeFrame":58},"Number of Dermatomal Sensory Block Levels After Epidural Test Dose","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)",{"measure":60,"description":61,"timeFrame":62},"Duration of Labor Epidural Catheter Unused Time","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)",{"measure":64,"description":65,"timeFrame":66},"Frequency of Labor Epidural Top-Up Doses","The total number of supplemental epidural local anesthetic bolus doses administered during labor prior to delivery.","Intrapartum (from labor epidural placement until delivery)",{"measure":68,"description":69,"timeFrame":70},"Postoperative Pain Intensity via Numeric Rating Scale (NRS-11)","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)",{"measure":72,"description":73,"timeFrame":74},"Patient Satisfaction Score With Labor Analgesia","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])",{"measure":76,"description":77,"timeFrame":74},"Patient Satisfaction Score With Tubal Ligation Anesthesia","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\").","FEMALE","18 Years",null,false,{"inclusion":83,"exclusion":88,"raw_text":97},[84,85,86,87],"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",[89,90,91,92,93,94,95,96],"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","Inclusion Criteria\n\n* Age ≥ 18 years\n* Postpartum women electing to undergo tubal ligation with an indwelling labor epidural catheter\n* Ability to provide informed consent in English\n* Vaginal delivery\n\nExclusion Criteria\n\n* Parturients not receiving labor epidural analgesia or receiving an alternative anesthetic technique during labor and delivery\n* Epidural catheter located \\>2 cm from the documented insertion depth at initial placement\n* Planned elective cesarean delivery\n* Chronic pain conditions (e.g., chronic low back pain, sickle cell disease)\n* Chronic opioid use disorder\n* Chronic gabapentin use\n* Uncontrolled mood disorders that, in the investigator's judgment, may interfere with study participation or interpretation of study outcomes\n* Prisoners or incarcerated individuals",[99,100],"ADULT","OLDER_ADULT",[102],{"facility":103,"status":8,"city":104,"state":105,"zip":106,"country":107,"geoPoint":108},"The Ohio State University","Columbus","Ohio","43210","United States",{"lat":109,"lon":110},39.96118,-82.99879,[112,117],{"name":113,"role":114,"phone":115,"email":116},"Ling-Qun Hu, MD","CONTACT","6142933559","LingQun.Hu@osumc.edu",{"name":118,"role":114,"phone":115,"email":119},"Alberto Uribe Vega","alberto.uribe@osumc.edu",[],[],[],{"nct_id":4,"conditions":124,"biomarkers":127},[125,126],"Epidural Catheter Dysfunction","Tubal Ligation",[],{"nct_id":4,"found":15,"summary":129,"prompt_version":139},{"design":130,"status":131,"heading":132,"summary":133,"follow_up":134,"word_count":135,"commitments":136,"compensation":137,"drugs_mentioned":138},"This is a pilot study involving 120 women. It is an interventional study, meaning participants will receive a specific assessment.","completed","CompuFlo® CathCheck™ System for Epidural Function Before Tubal Ligation","This study is looking at a new way to check if an epidural catheter (a small tube placed in your back for pain relief) is working correctly before you have a tubal ligation (a permanent birth control procedure) after childbirth. It uses a device called the CompuFlo® CathCheck™ System to see if it can accurately tell if your epidural is functional compared to standard methods. The goal is to reduce the number of times an epidural doesn't work when reactivated, which can lead to needing different types of anesthesia. You might be able to join if you are a woman aged 18 or older, have just had a vaginal delivery, and are planning to have a tubal ligation with an existing epidural catheter. The study aims to see how often the epidural can be successfully reactivated for your procedure.","The primary outcome is measured from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure.",139,"You would have your labor epidural catheter evaluated using the CompuFlo® CathCheck™ System after a standard test-dose and before your tubal ligation.","Not stated in the trial record.",[],"v2"]