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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional epidural group | Active Comparator | The traditional approach to placing thoracic epidurals by loss-of-resistance technique using a ground glass syringe will be used in this group. |
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| CompuFlo epidural group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traditional (loss-of-resistance technique) thoracic epidural placement | Device | Thoracic epidurals will be administered using the traditional loss-of resistance technique. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yatish S Ranganath, MD | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14612482 | Result | 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. | |
| 12218518 | Result | 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. |
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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.
Individual participant data will be available for sharing immediately after publication and ending 5 years following article publication.
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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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique. |
| FG001 | 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. CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Maximum 20 minutes post administration of epidural test dose |
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The data was collected from the time of consent until 48 hours post procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. Traditional (loss-of-resistance technique) thoracic epidural placement: Thoracic epidurals will be administered using the traditional loss-of resistance technique. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vice Chair for Research | University of Iowa Hospitals and Clinics | 319-335-9595 | donna-hammond@uiowa.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2019 | Aug 24, 2022 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 15, 2019 | Aug 24, 2022 | SAP_004.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 15, 2019 | Aug 24, 2022 | ICF_005.pdf |
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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).
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| CompuFlo thoracic epidural placement | Device | Pressure sensing technology to consistently and accurately identify the thoracic epidural space. |
|
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 |
| 18936379 | Result | 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. |
| 26469364 | Result | 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. |
| 27922948 | Result | 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. |
| 25172504 | Result | 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. |
| 38190338 | Derived | Ranganath YS, Ramanujam V, Al-Hassan Q, Sibenaller Z, Seering MS, Singh TSS, Punia S, Parra MC, Wong CA, Sondekoppam RV. Loss-of-Resistance Versus Dynamic Pressure-Sensing Technology for Successful Placement of Thoracic Epidural Catheters: A Randomized Clinical Trial. Anesth Analg. 2024 Jul 1;139(1):201-210. doi: 10.1213/ANE.0000000000006792. Epub 2024 Jun 17. |
| BG001 |
| 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. CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
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. CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space. |
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| Secondary | Amount of Time Required to Complete the Procedure | Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient | Posted | Mean | Standard Deviation | minutes | During procedure, assessed up to 15 minutes |
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| Secondary | 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. | Posted | Number | participants | Up to 20 minutes post administration of epidural test dose |
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| Secondary | 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]). | Posted | Mean | Standard Deviation | mmHg | Up to 20 minutes post administration of epidural test dose |
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| Secondary | 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. | Posted | Count of Participants | Participants | Up to 20 minutes post administration of epidural test dose |
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| Secondary | 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?" | Posted | Number | participants | During procedure, assessed up to 15 minutes |
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| Secondary | 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. | Posted | Count of Participants | Participants | During procedure, assessed up to 15 minutes |
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| Secondary | 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. | Posted | Count of Participants | Participants | During procedure, assessed up to 15 minutes |
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| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | 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. CompuFlo thoracic epidural placement: Pressure sensing technology to consistently and accurately identify the thoracic epidural space. | 0 | 60 | 0 | 60 | 0 | 60 |
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| No change in cold sensation |
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