Thoracic Epidural Anesthesia
Conditions
Keywords
CompuFlo; dynamic pressure sensing
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.
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.
Interventions
DEVICETraditional (loss-of-resistance technique) thoracic epidural placement
Thoracic epidurals will be administered using the traditional loss-of resistance technique.
DEVICECompuFlo thoracic epidural placement
Pressure sensing technology to consistently and accurately identify the thoracic epidural space.
Sponsors
YATISH SIDDAPURA RANGANATH
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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).
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Successful Thoracic Epidural Catheter Placement | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Reported Loss of Cold Sensation at Various Time Points | 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. |
| Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure | 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 \[systolic blood pressure (SBP) - DBP\]). |
| Number of Participants With Significant Change in Systolic Blood Pressure | 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. |
| Amount of Time Required to Complete the Procedure | During procedure, assessed up to 15 minutes | Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient |
| Number of Participants With a Positive Meniscus Test | 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. |
| Number of Participants With Unintentional Dural Puncture | 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. |
| Number of Participants Whose Provider Answered Yes or No to Ease of Catheter Placement | 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? |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 57 |
| 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. | 60 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | CompuFlo Epidural Group | Total | Traditional Epidural Group |
|---|---|---|---|
| Age, Continuous | 57.9 years STANDARD_DEVIATION 11.38 | 57.9 years STANDARD_DEVIATION 11.36 | 57.9 years STANDARD_DEVIATION 11.34 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 60 participants | 117 participants | 57 participants |
| Sex: Female, Male Female | 35 Participants | 65 Participants | 30 Participants |
| Sex: Female, Male Male | 25 Participants | 52 Participants | 27 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 57 | 0 / 60 |
| other Total, other adverse events | 0 / 57 | 0 / 60 |
| serious Total, serious adverse events | 0 / 57 | 0 / 60 |
Outcome results
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.
Time frame: Maximum 20 minutes post administration of epidural test dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Epidural Group | Number of Participants With Successful Thoracic Epidural Catheter Placement | 52 Participants |
| CompuFlo Epidural Group | Number of Participants With Successful Thoracic Epidural Catheter Placement | 58 Participants |
Secondary
Amount of Time Required to Complete the Procedure
Tuohy needle skin puncture to removal of tuohy (for the last time) from the patient
Time frame: During procedure, assessed up to 15 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Traditional Epidural Group | Amount of Time Required to Complete the Procedure | 8.02 minutes | Standard Deviation 7.4 |
| CompuFlo Epidural Group | Amount of Time Required to Complete the Procedure | 7.4 minutes | Standard Deviation 6.6 |
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 \[systolic blood pressure (SBP) - DBP\]).
Time frame: Up to 20 minutes post administration of epidural test dose
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Traditional Epidural Group | Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure | Pre-procedure (mmHg) | 102 mmHg | Standard Deviation 14 |
| Traditional Epidural Group | Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure | 20-minutes after initial test dose | 85 mmHg | Standard Deviation 16 |
| CompuFlo Epidural Group | Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure | Pre-procedure (mmHg) | 102 mmHg | Standard Deviation 11 |
| CompuFlo Epidural Group | Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure | 20-minutes after initial test dose | 83 mmHg | Standard Deviation 14 |
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.
Time frame: Up to 20 minutes post administration of epidural test dose
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Traditional Epidural Group | Number of Participants Who Reported Loss of Cold Sensation at Various Time Points | Loss of cold sensation-10 minutes | 28 participants |
| Traditional Epidural Group | Number of Participants Who Reported Loss of Cold Sensation at Various Time Points | Loss of cold sensation-20 minutes | 24 participants |
| Traditional Epidural Group | Number of Participants Who Reported Loss of Cold Sensation at Various Time Points | No change in cold sensation | 5 participants |
| CompuFlo Epidural Group | Number of Participants Who Reported Loss of Cold Sensation at Various Time Points | Loss of cold sensation-10 minutes | 18 participants |
| CompuFlo Epidural Group | Number of Participants Who Reported Loss of Cold Sensation at Various Time Points | Loss of cold sensation-20 minutes | 40 participants |
| CompuFlo Epidural Group | Number of Participants Who Reported Loss of Cold Sensation at Various Time Points | No change in cold sensation | 2 participants |
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?
Time frame: During procedure, assessed up to 15 minutes
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Traditional Epidural Group | Number of Participants Whose Provider Answered Yes or No to Ease of Catheter Placement | Yes | 57 participants |
| Traditional Epidural Group | Number of Participants Whose Provider Answered Yes or No to Ease of Catheter Placement | No | 0 participants |
| CompuFlo Epidural Group | Number of Participants Whose Provider Answered Yes or No to Ease of Catheter Placement | Yes | 60 participants |
| CompuFlo Epidural Group | Number of Participants Whose Provider Answered Yes or No to Ease of Catheter Placement | No | 0 participants |
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.
Time frame: During procedure, assessed up to 15 minutes
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Traditional Epidural Group | Number of Participants With a Positive Meniscus Test | Positive | 57 Participants |
| Traditional Epidural Group | Number of Participants With a Positive Meniscus Test | Negative | 0 Participants |
| CompuFlo Epidural Group | Number of Participants With a Positive Meniscus Test | Positive | 57 Participants |
| CompuFlo Epidural Group | Number of Participants With a Positive Meniscus Test | Negative | 3 Participants |
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.
Time frame: Up to 20 minutes post administration of epidural test dose
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Epidural Group | Number of Participants With Significant Change in Systolic Blood Pressure | 41 Participants |
| CompuFlo Epidural Group | Number of Participants With Significant Change in Systolic Blood Pressure | 38 Participants |
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.
Time frame: During procedure, assessed up to 15 minutes
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Traditional Epidural Group | Number of Participants With Unintentional Dural Puncture | 2 Participants |
| CompuFlo Epidural Group | Number of Participants With Unintentional Dural Puncture | 2 Participants |