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
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ling-Qun Hu, MD
- 電話番号：6142933559
- メール：lingqun.hu@osumc.edu
研究連絡先のバックアップ
- 名前：Alberto Uribe Vega
- 電話番号：6142933559
- メール：alberto.uribe@osumc.edu
研究場所
-
-
Ohio
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Columbus、Ohio、アメリカ、43210
- 募集
- The Ohio State University
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rate of Successful Labor Epidural Catheter Reactivation
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Sensitivity of the CompuFlo® CathCheck™ System
時間枠：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.
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Pre-procedural (prior to epidural reactivation)
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Specificity of the CompuFlo® CathCheck™ System
時間枠：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
時間枠：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)
|
|
Number of Dermatomal Sensory Block Levels After Epidural Test Dose
時間枠：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
時間枠：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)
|
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Frequency of Labor Epidural Top-Up Doses
時間枠：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)
時間枠：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
時間枠：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
時間枠：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])
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2023H0188
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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