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
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|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).|
|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|
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.
- 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.
- 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
- 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.
- 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.
- Ease of catheter placement/threading [ Time Frame: Immediate-during the procedure ]Compare the ease of catheter threading through the needle between the groups.
- 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.
- 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.
- Measure post-operative -Opioid Usage [ Time Frame: First 48 hours post procedure ]Chart review to compare opioid consumption in both groups
- 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.
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03826186
|Contact: Yatish S. Ranganath, MDemail@example.com|
|Contact: Zita A Sibenaller, PhDfirstname.lastname@example.org|
|United States, Iowa|
|University of Iowa Hospitals and Clinics||Recruiting|
|Iowa City, Iowa, United States, 52242|
|Contact: Yatish Siddapura Ranganath, MD email@example.com|
|Contact: Alicia Manning firstname.lastname@example.org|
|Principal Investigator:||Yatish S Ranganath, MD||University of Iowa|