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Completed

NCT Number: NCT03826186

CompuFlo Thoracic Epidural Study

Traditionally, loss-of-resistance (LOR) to air or saline with a special ground-glass syringe is the technique used to identify epidural space, but failure rates up to 30% have been reported using this technique for thoracic epidural placement. This failure rate has sparked the search for newer techniques to improve the success rate for placement.The CompuFlo epidural system is a device that provides anesthesiologists and other healthcare providers the ability to quantitatively determine and document the pressure at the needle tip in real time. The device's proprietary dynamic pressure sensing technology (DPS) allows it to provide objective visual and audible in-tissue pressure feedback that allows anesthesiologists to identify the epidural space. The purpose this research study is to compare the success rate of the two different approaches (traditional method v/s CompuFlo assisted) to thoracic epidural placement.

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Key information

Conditions

Thoracic Epidural Anesthesia

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

Traditional technique vs CompuFlo use: Using the traditional technique (loss-of-resistance technique), the epidural needle is advanced through the subcutaneous tissues with the needle stylet in place until the needle tip is positioned in the interspinous ligament-this is noted by the proceduralist by an increase in tissue resistance (attempted injection into ligamentous tissue is met with high resistance). The stylet or introducer is removed, and a ground-glass syringe filled with 2-3 mL of saline with an air bubble is attached to the hub of the epidural needle. If the tip of the needle is within the ligament, gentle attempts at injection are met with resistance, and injection of the saline is not possible. The needle is then slowly advanced, millimeter by millimeter, with either continuous or rapidly repeating attempts at injection. As the tip of the needle enters the posterior epidural space, a sudden loss of resistance is noted, and the saline injects easily. Once the needle tip is in the epidural space, the epidural catheter is threaded through the needle and the needle is removed, leaving the catheter sited in the epidural space.

The CompuFlo technique complements this basic technique. Similar to the traditional technique, the needle is advanced through the subcutaneous tissues with the stylet in place until the interspinous ligament is entered, as noted by an increase in tissue resistance. After removing the stylet, flexible tubing from the CompuFlo disposable tubing-syringe set is attached to the hub of the needle instead of the traditional ground-glass syringe. The fluid-filled syringe is placed in the CompuFlo device. The needle is then advanced continuously with the device electronically sensing pressure in real time, providing a numerical value (100 to 150 mm Hg) on the read-out screen. As the tip of the needle enters the posterior epidural space, a sudden loss of resistance (associated with a significant loss of pressure to less than 50 mm Hg or 50% of the starting pressure) is noted. The pressure drop needs to be sustained for at least 5 seconds. An audio signal also signals the acute change in pressure.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: 18 to 70
  • BMI: 18 to 50 kg/m2
  • Require pain control for major thoracic or abdominal surgeries
  • Require pain control for rib fractures
  • English is the subject's first language
  • Must be able to signed informed consent

Exclusion criteria

  • Age: Less than 18 and older than 70
  • Must be free of significant valvular heart disease
  • Pregnant women
  • Prisoners
  • Contraindication to thoracic epidural anesthesia
  • Allergy or hypersensitivity to local anesthetics
  • Unable to provide written informed consent

Treatment and study plan

Traditional (loss-of-resistance technique) thoracic epidural placement

Device

Thoracic epidurals will be administered using the traditional loss-of resistance technique.

CompuFlo thoracic epidural placement

Device

Pressure sensing technology to consistently and accurately identify the thoracic epidural space.

Primary outcomes

  1. Number of Participants With Successful Thoracic Epidural Catheter Placement

    Time frame: Maximum 20 minutes post administration of epidural test dose

    Successful placement of thoracic epidural analgesia will be determined by the loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.

Secondary outcomes

  1. Amount of Time Required to Complete the Procedure

    Time frame: During procedure, assessed up to 15 minutes

    Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient

  2. Number of Participants Who Reported Loss of Cold Sensation at Various Time Points

    Time frame: Up to 20 minutes post administration of epidural test dose

    Record the time it takes for loss of cold sensation on the chest or abdomen depending on the site of epidural placement using a dermatome bilaterally. Subjects will be tested at 10 minute intervals.

  3. Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure

    Time frame: Up to 20 minutes post administration of epidural test dose

    Blood pressure was measured at baseline (patient check-in) and then every 5 minutes after administration of test dose in both groups. To observe the trend in blood pressure changes, the mean arterial pressure was used. Results are reported as mean arterial pressure (MAP) since MAP is the average arterial pressure throughout one cardiac cycle, systole and diastole. The MAP was calculated based on the available MAP formula (MAP=diastolic blood pressure (DBP) + 1/3 [systolic blood pressure (SBP) - DBP]).

  4. Number of Participants With Significant Change in Systolic Blood Pressure

    Time frame: Up to 20 minutes post administration of epidural test dose

    A fall in systolic blood pressure by 20% or more from the baseline up to 20 minutes after the initial test dose was considered a significant change.

  5. Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement

    Time frame: During procedure, assessed up to 15 minutes

    The provider was asked to evaluate the ease of catheter threading through the needle after the loss of resistance. This is a "yes" or "no" evaluation asked and answered at the end of the procedure. The question asked was "Was the catheter placement (threading) smooth after loss of resistance?"

  6. Number of Participants With a Positive Meniscus Test

    Time frame: During procedure, assessed up to 15 minutes

    The test involves 3 steps after removal of the filter: (i) the open end of the epidural catheter is lifted and the liquid meniscus present in the catheter is observed to drop rapidly; (ii) the open end of the epidural catheter is lowered and the liquid meniscus is again observed to fill the catheter with clear liquid and no blood; (iii) the presence of air in the catheter during backflow confirms the correct position in the epidural space relative to a position in the subarachnoid space. If the above changes are observed - that would help in secondary confirmation of the epidural space and we would call that a positive test. If the above changes are not observed, it was called as a negative test.

  7. Number of Participants With Unintentional Dural Puncture

    Time frame: During procedure, assessed up to 15 minutes

    The number of unintentional dural punctures during the traditional loss-of-resistance methods will be compared to the unintentional dural punctures while using the CompuFlo assisted technology.

Sponsors and collaborators

Lead sponsor

YATISH SIDDAPURA RANGANATH

Other

Registry information

Official study title

Traditional Loss-of-resistance Technique vs Compuflo-aided Technology for Placement of a Thoracic Epidural Catheter: a Randomized Trial of the Effect on the Success Rate

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2019
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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