CompuFlo Thoracic Epidural Study
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 3/31/2019 |
| Start Date: | March 26, 2019 |
| End Date: | January 1, 2023 |
| Contact: | Yatish S. Ranganath, MD |
| Email: | yatish-ranganath@uiowa.edu |
| Phone: | 319-467-6798 |
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.
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.
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.
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
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