Anesthesia, EpiduralNCT07720908
Using the CompuFlo® CathCheck™ System to Check Epidural Catheter Function Before Tubal Ligation: A Pilot Study
A study testing CompuFlo® CathCheck™ System Assessment in people with Anesthesia, Epidural, run by Ohio State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anesthesia, Epidural
- What is being tested?
- CompuFlo® CathCheck™ System Assessment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2024to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Ohio State University
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Anesthesia, Epidural
- Being tested
- CompuFlo® CathCheck™ System Assessment
- Keywords
- Labor epidural catheter, Epidural catheter dysfunction, CompuFlo CathCheck System, Tubal ligation in parturients
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CompuFlo® CathCheck™ System AssessmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Labor Epidural Reactivation Cohort | Experimental | 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. Receives: Device: CompuFlo® CathCheck™ System Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)
Secondary outcomes (9)
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.
Measured: Pre-procedural (prior to epidural reactivation)
Specificity of the CompuFlo® CathCheck™ System
The specificity percentage of the CompuFlo® CathCheck™ System for correctly identifying non-functional labor epidural catheters.
Measured: Pre-procedural (prior to epidural reactivation)
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.
Measured: Pre-procedural (prior to epidural reactivation)
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.
Measured: Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)
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.
Measured: Periprocedural (from delivery until epidural reactivation)
Frequency of Labor Epidural Top-Up Doses
The total number of supplemental epidural local anesthetic bolus doses administered during labor prior to delivery.
Measured: Intrapartum (from labor epidural placement until delivery)
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."
Measured: Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)
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").
Measured: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
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").
Measured: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2026
- Study start19 Dec 2024
- Primary completion31 Oct 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, EpiduralStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will undergo the same study procedures. Following vaginal delivery and prior to postpartum tubal ligation, participants with an indwelling labor epidural catheter will receive the standard clinical epidural test dose and assessment, followed by evaluation with the CompuFlo® CathCheck™ System to detect epidural pulsatile waveform pressure. The diagnostic performance of the CompuFlo® system will be compared with the clinical reference standard for successful epidural catheter reactivation.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ling-Qun Hu, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07720908
- Sponsor's protocol ID
- 2023H0188
- Status last verified
- Jul 2026
- First submitted
- 13 Jul 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Labor Epidural Catheter Dysfunction for Tubal Ligation in Parturients Using CompuFlo® CathCheck™ System: A Pilot Study
- ClinicalTrials.gov ID
- NCT07720908
- Acronym / sponsor ID
- 2023H0188
- Conditions
- Anesthesia, Epidural
- Keywords
- Labor epidural catheter, Epidural catheter dysfunction, CompuFlo CathCheck System, Tubal ligation in parturients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 19 Dec 2024 (actual)
- Primary completion
- 31 Oct 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 22 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will undergo the same study procedures. Following vaginal delivery and prior to postpartum tubal ligation, participants with an indwelling labor epidural catheter will receive the standard clinical epidural test dose and assessment, followed by evaluation with the CompuFlo® CathCheck™ System to detect epidural pulsatile waveform pressure. The diagnostic performance of the CompuFlo® system will be compared with the clinical reference standard for successful epidural catheter reactivation.
| Arm | Type | Receives |
|---|---|---|
| Labor Epidural Reactivation Cohort | Experimental | Device: CompuFlo® CathCheck™ System AssessmentPostpartum 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CompuFlo® CathCheck™ System AssessmentEvaluation 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. | Device | Labor Epidural Reactivation Cohort |
Primary outcome
Rate of Successful Labor Epidural Catheter Reactivation
Time frame: 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).
9 secondary outcomes
Sensitivity of the CompuFlo® CathCheck™ System
Time frame: Pre-procedural (prior to epidural reactivation)
Specificity of the CompuFlo® CathCheck™ System
Time frame: Pre-procedural (prior to epidural reactivation)
Area Under the Receiver Operating Characteristic (ROC) Curve (AUC) of the CompuFlo® CathCheck™ System
Time frame: Pre-procedural (prior to epidural reactivation)
Number of Dermatomal Sensory Block Levels After Epidural Test Dose
Time frame: Periprocedural (at the time of labor epidural placement and at the time of epidural reactivation)
Duration of Labor Epidural Catheter Unused Time
Time frame: Periprocedural (from delivery until epidural reactivation)
Frequency of Labor Epidural Top-Up Doses
Time frame: Intrapartum (from labor epidural placement until delivery)
Postoperative Pain Intensity via Numeric Rating Scale (NRS-11)
Time frame: Periprocedural (upon admission to the post-anesthesia care unit [PACU] and at discharge from the PACU)
Patient Satisfaction Score With Labor Analgesia
Time frame: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
Patient Satisfaction Score With Tubal Ligation Anesthesia
Time frame: Periprocedural (prior to discharge from the post-anesthesia care unit [PACU])
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CompuFlo® CathCheck™ System Assessment in people with Anesthesia, Epidural, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ling-Qun Hu, MD (6142933559, LingQun.Hu@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Successful Labor Epidural Catheter Reactivation (time frame: Periprocedural (from the start of epidural reactivation assessment until the completion of the postpartum tubal ligation procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.