Trial Outcomes & Findings for CompuFlo Thoracic Epidural Study (NCT NCT03826186)
NCT ID: NCT03826186
Last Updated: 2022-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
120 participants
Primary outcome timeframe
Maximum 20 minutes post administration of epidural test dose
Results posted on
2022-10-19
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
60
|
|
Overall Study
COMPLETED
|
57
|
60
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
Total
n=117 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.9 years
STANDARD_DEVIATION 11.34 • n=57 Participants
|
57.9 years
STANDARD_DEVIATION 11.38 • n=60 Participants
|
57.9 years
STANDARD_DEVIATION 11.36 • n=117 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=57 Participants
|
35 Participants
n=60 Participants
|
65 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=57 Participants
|
25 Participants
n=60 Participants
|
52 Participants
n=117 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
57 participants
n=57 Participants
|
60 participants
n=60 Participants
|
117 participants
n=117 Participants
|
PRIMARY outcome
Timeframe: Maximum 20 minutes post administration of epidural test doseSuccessful 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.
Outcome measures
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
|---|---|---|
|
Number of Participants With Successful Thoracic Epidural Catheter Placement
|
52 Participants
|
58 Participants
|
SECONDARY outcome
Timeframe: During procedure, assessed up to 15 minutesTuohy needle skin puncture to removal of tuohy (for the last time) from the patient
Outcome measures
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
|---|---|---|
|
Amount of Time Required to Complete the Procedure
|
8.02 minutes
Standard Deviation 7.4
|
7.4 minutes
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: Up to 20 minutes post administration of epidural test doseRecord 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.
Outcome measures
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
|---|---|---|
|
Number of Participants Who Reported Loss of Cold Sensation at Various Time Points
Loss of cold sensation-10 minutes
|
28 participants
|
18 participants
|
|
Number of Participants Who Reported Loss of Cold Sensation at Various Time Points
Loss of cold sensation-20 minutes
|
24 participants
|
40 participants
|
|
Number of Participants Who Reported Loss of Cold Sensation at Various Time Points
No change in cold sensation
|
5 participants
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 20 minutes post administration of epidural test doseBlood 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 \[systolic blood pressure (SBP) - DBP\]).
Outcome measures
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
|---|---|---|
|
Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure
Pre-procedure (mmHg)
|
102 mmHg
Standard Deviation 14
|
102 mmHg
Standard Deviation 11
|
|
Mean Arterial Pressure at Baseline and 20 Minutes Post Procedure
20-minutes after initial test dose
|
85 mmHg
Standard Deviation 16
|
83 mmHg
Standard Deviation 14
|
SECONDARY outcome
Timeframe: Up to 20 minutes post administration of epidural test doseA 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.
Outcome measures
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
|---|---|---|
|
Number of Participants With Significant Change in Systolic Blood Pressure
|
41 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: During procedure, assessed up to 15 minutesThe 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?"
Outcome measures
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
|---|---|---|
|
Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement
Yes
|
57 participants
|
60 participants
|
|
Number of Participants Whose Provider Answered "Yes" or "No" to Ease of Catheter Placement
No
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: During procedure, assessed up to 15 minutesThe 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.
Outcome measures
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
|---|---|---|
|
Number of Participants With a Positive Meniscus Test
Positive
|
57 Participants
|
57 Participants
|
|
Number of Participants With a Positive Meniscus Test
Negative
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During procedure, assessed up to 15 minutesThe 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.
Outcome measures
| Measure |
Traditional Epidural Group
n=57 Participants
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.
|
CompuFlo Epidural Group
n=60 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.
|
|---|---|---|
|
Number of Participants With Unintentional Dural Puncture
|
2 Participants
|
2 Participants
|
Adverse Events
Traditional Epidural Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CompuFlo Epidural Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Vice Chair for Research
University of Iowa Hospitals and Clinics
Phone: 319-335-9595
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place