CompuFlo Thoracic Epidural Study

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

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.

Study Overview

• Status: Completed
• Conditions: Thoracic Epidural Anesthesia
• Intervention / Treatment: Device: Traditional (loss-of-resistance technique) thoracic epidural placement; Device: CompuFlo thoracic epidural placement

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Successful Thoracic Epidural Catheter Placement	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.	Maximum 20 minutes post administration of epidural test dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of Time Required to Complete the Procedure	Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient	During procedure, assessed up to 15 minutes
Number of Participants Who Reported Loss of Cold Sensation at Various Time Points	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.	Up to 20 minutes post administration of epidural test dose
Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure	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]).	Up to 20 minutes post administration of epidural test dose
Number of Participants With Significant Change in Systolic Blood Pressure	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.	Up to 20 minutes post administration of epidural test dose
Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement	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?"	During procedure, assessed up to 15 minutes
Number of Participants With a Positive Meniscus Test	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.	During procedure, assessed up to 15 minutes
Number of Participants With Unintentional Dural Puncture	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.	During procedure, assessed up to 15 minutes

Collaborators and Investigators

• Sponsor: YATISH SIDDAPURA RANGANATH
• Investigators: Principal Investigator: Yatish S Ranganath, MD, University of Iowa

Publications and helpful links

General Publications

• Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
• Carli F, Mayo N, Klubien K, Schricker T, Trudel J, Belliveau P. Epidural analgesia enhances functional exercise capacity and health-related quality of life after colonic surgery: results of a randomized trial. Anesthesiology. 2002 Sep;97(3):540-9. doi: 10.1097/00000542-200209000-00005.
• Popping DM, Elia N, Marret E, Remy C, Tramer MR. Protective effects of epidural analgesia on pulmonary complications after abdominal and thoracic surgery: a meta-analysis. Arch Surg. 2008 Oct;143(10):990-9; discussion 1000. doi: 10.1001/archsurg.143.10.990.
• Leurcharusmee P, Arnuntasupakul V, Chora De La Garza D, Vijitpavan A, Ah-Kye S, Saelao A, Tiyaprasertkul W, Finlayson RJ, Tran DQ. Reliability of Waveform Analysis as an Adjunct to Loss of Resistance for Thoracic Epidural Blocks. Reg Anesth Pain Med. 2015 Nov-Dec;40(6):694-7. doi: 10.1097/AAP.0000000000000313.
• Parra MC, Washburn K, Brown JR, Beach ML, Yeager MP, Barr P, Bonham K, Lamb K, Loftus RW. Fluoroscopic Guidance Increases the Incidence of Thoracic Epidural Catheter Placement Within the Epidural Space: A Randomized Trial. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):17-24. doi: 10.1097/AAP.0000000000000519.
• Gong Y, Shi H, Wu J, Labu D, Sun J, Zhong H, Li L, Xin X, Wang L, Wu L, Ma D. Pressure waveform-guided epidural catheter placement in comparison to the loss-of-resistance conventional method. J Clin Anesth. 2014 Aug;26(5):395-401. doi: 10.1016/j.jclinane.2014.01.015. Epub 2014 Aug 27.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2019
• Primary Completion (ACTUAL): January 1, 2022
• Study Completion (ACTUAL): June 1, 2022

Study Registration Dates

• First Submitted: January 22, 2019
• First Submitted That Met QC Criteria: January 30, 2019
• First Posted (ACTUAL): February 1, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: CompuFlo; dynamic pressure sensing
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aneurysm; Aneurysm, Dissecting
• Other Study ID Numbers: 201812716

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.
• IPD Sharing Time Frame: Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
• IPD Sharing Access Criteria: Individual participant data will be accessible to researchers who provide a methodologically sound proposal, to achieve aims in the approved proposal.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No