CompuFlo Thoracic Epidural Study
Condition: Thoracic Epidural Anesthesia
MeSH terms: Aortic Dissection
Study type: Interventional

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.
    

Intervention name(s): Traditional (loss-of-resistance technique) thoracic epidural placement; CompuFlo thoracic epidural placement
Intervention type(s): Device; Device
Intervention description(s): Thoracic epidurals will be administered using the traditional loss-of resistance technique.; Pressure sensing technology to consistently and accurately identify the thoracic epidural space.
Allocation: Randomized
Intervention model: Parallel Assignment
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).
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: CompuFlo; dynamic pressure sensing