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CompuFlo Thoracic Epidural Study

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ClinicalTrials.gov Identifier: NCT03826186
Recruitment Status : Recruiting
First Posted : February 1, 2019
Last Update Posted : March 29, 2019
Sponsor:
Information provided by (Responsible Party):
YATISH SIDDAPURA RANGANATH, University of Iowa

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Thoracic Epidural Anesthesia Device: Traditional (loss-of-resistance technique) thoracic epidural placement Device: CompuFlo thoracic epidural placement Not Applicable

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Thoracic epidurals are administered. After randomization, one group will receive thoracic epidurals in the traditional way (control group) and the other with CompuFlo assistance (study group).
Masking: Single (Participant)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : January 1, 2023

Arm Intervention/treatment
Active Comparator: Traditional epidural group
The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group.
Device: Traditional (loss-of-resistance technique) thoracic epidural placement
Thoracic epidurals will be administered using the traditional loss-of resistance technique.

Experimental: CompuFlo epidural group
This device (CompuFlo) will aid in correct placement of the epidural by electronically sensing pressure in real time and by providing a numerical value on a read out screen to determine a loss of resistance. There is also an audio signal that signals a loss of resistance.
Device: CompuFlo thoracic epidural placement
Pressure sensing technology to consistently and accurately identify the thoracic epidural space.




Primary Outcome Measures :
  1. Calculate success rate of thoracic epidural catheter placement-Traditional versus CompuFlo [ 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 5 minute intervals.


Secondary Outcome Measures :
  1. Calculate the amount of time required for the procedure [ Time Frame: Immediate-during the procedure ]
    Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient

  2. Time taken for loss of cold sensation [ 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 5 minute intervals.

  3. Measure change in blood pressure [ Time Frame: Up to 20 minutes post administration of epidural test dose ]
    Measure blood pressure every 5 minutes after administration of test dose in both groups. The data collected will be compared with base-line data (pre-procedure data when the patient checks in). A fall in systolic blood pressure by 20% or more from the base-line will considered a significant change.

  4. Ease of catheter placement/threading [ Time Frame: Immediate-during the procedure ]
    Compare the ease of catheter threading through the needle between the groups.

  5. Meniscus test - Changes observed in the epidural catheter with changes in position [ Time Frame: Immediate-during the procedure ]
    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, we would call that a negative test.

  6. Measure post-operative pain scores [ Time Frame: First 48 hours post procedure. ]
    Chart review to compare pain scores in both groups. Numeric Rating Scale (NRS) 0-10: The numeric values are on a continuous scale from 0 to 10 with 0 indicating no pain, 5 being moderate pain and 10 reported as intense pain.

  7. Measure post-operative -Opioid Usage [ Time Frame: First 48 hours post procedure ]
    Chart review to compare opioid consumption in both groups

  8. Calculate unintentional dural puncture [ Time Frame: Immediate-during the procedure ]
    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.

  9. Analyze pressure levels recorded in CompuFlo group [ Time Frame: Immediate-during the procedure ]
    The pressure levels recorded on the device in the Compuflo group during epidural placement will be analyzed. This will help us to learn about the pressure levels (in mm Hg) reached in different regions as the needle is advanced: Pressure before entering the space; Pressure after entry into the epidural space; Change in pressure between the two spaces.

  10. Analyze recorded waveforms in the CompuFlo group [ Time Frame: Immediate-during the procedure ]
    The waveform recorded on the device during epidural placement will be analyzed to learn the patterns predictive of successful placement.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826186


Contacts
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Contact: Yatish S. Ranganath, MD 319-467-6798 yatish-ranganath@uiowa.edu
Contact: Zita A Sibenaller, PhD 319-356-8878 zita-sibenaller@uiowa.edu

Locations
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United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Yatish Siddapura Ranganath, MD       yatish-ranganath@uiowa.edu   
Contact: Alicia Manning       alicia-manning@uiowa.edu   
Sponsors and Collaborators
YATISH SIDDAPURA RANGANATH
Investigators
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Principal Investigator: Yatish S Ranganath, MD University of Iowa

Publications of Results:

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Responsible Party: YATISH SIDDAPURA RANGANATH, Clinical Assistant Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03826186     History of Changes
Other Study ID Numbers: 201812716
First Posted: February 1, 2019    Key Record Dates
Last Update Posted: March 29, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data (IPD) collected during the trial, after deidentification will be shared with researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal. Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
Access Criteria: Individual participant data will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by YATISH SIDDAPURA RANGANATH, University of Iowa:
CompuFlo; dynamic pressure sensing