Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Lumbar Spine Surgery
- Sponsor
- Hospital for Special Surgery, New York
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Real time confirmation of epidural space with loss of resistance technique
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The goal of this clinical trial is to test the BrightPoint Epidural device as the first system to use multispectral reflectometry to find the epidural space in lumbar neuraxial procedures requiring epidural needle. The main questions it aims to answer are:
- Is the device a qualitatively effective secondary confirmation of Loss of Resistance?
- Is the device a qualitatively effective training tool for educating trainees in how to perform lumbar epidurals?
Participants will undergo a neuraxial procedure in which the attending anesthesiologist will use the BrightPoint epidural device to form an opinion on its effectiveness in confirming epidural space access.
Detailed Description
There have been few improvements to the LOR technique from a device standpoint in recent years, and those that options do exist have not achieved widespread clinical use. The devices that do exist are variations on pressure sensors, some automate the "resistance" by placing various systems in place to apply a pressure to the plunger so that it will inject when the epidural space is accessed without the practitioner doing it themselves. This concept is represented by devices such as the Epimatic syringe from Vygon. Others improve on this concept by monitoring the pressure required to inject a set volume of fluid, thus being able to differentiate between true and false losses, as during false losses the pressure will increase as more fluid is injected. This system is represented by the CompuFlo Device by Milestone Scientific. The BrightPoint Epidural device is the first system that utilizes multispectral reflectometry in order to identify the epidural space. This technology has the theoretical benefit over pressure-based systems of being able to identify and differentiate between different issue types (muscle, ligament, bone) as the needle is advanced towards the epidural space. Lumoptik, the company behind the BrightPoint Epidural device, is an early-stage startup based in Cleveland, Ohio. The main questions this trial aims to answer are: 1. Is the device a qualitatively effective secondary confirmation of Loss of Resistance? 2. Is the device a qualitatively effective training tool for educating trainees in how to perform lumbar epidurals? This trial is being conducted to improve our current standard of care in neuraxial placement of loss-of-resistance. While the loss of resistance technique is tried and true, especially in experienced hands, complications such as dural punctures, misplaced epidurals, patchy epidurals, neurologic injuries, and intravascular catheters can occur even in experienced hands. All of which can cause significant patient morbidity and costs to the healthcare system, and as is shown in the Lacombe attached, the effects of dural puncture can be long lived for the patient. There can also be a steep learning curve when learning the technique, with the frequency of inadvertent dural punctures significantly higher in the early stages of learning the procedure. Therefore, we as a specialty are obligated to evaluate potential improvements to our current way of practice to reduce the burden to our patients from the complications of our interventions.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Any patient undergoing a lumbar neuraxial procedure requiring epidural needle
- •Age 18-99
Exclusion Criteria
- •Previous lumbar spine surgery
- •Any known spinal abnormality that would interfere with successfully advancing a needle into the epidural space
- •Any patient requiring epidural needle longer than 4 inches
- •Any contraindication to neuraxial anesthesia
- •Tattoo at the site of epidural insertion
Outcomes
Primary Outcomes
Real time confirmation of epidural space with loss of resistance technique
Time Frame: Post-operation (after the surgery is complete)
On the post-procedure questionnaire, the anesthesiologist will report about whether the device identified epidural space in agreement with loss of resistance technique. If no, the outcome will be recorded as either a false positive (device signaled epidural space while needle was not in epidural space) or false negative (device did not signal epidural space while needle was in epidural space).
Secondary Outcomes
- Clinical (anesthesiologist) opinions on Lumoptik Bright Point Epidural device(Post-operation (after the surgery is complete))
- The percentage of Successful Neuraxial Procedures(Post-operation (after the surgery is complete))
- Color graphics aid in the identification of needle tips.(Post-operation (after the surgery is complete))
- The time it takes to insert the epidural needle into the patient's skin.(From "in OR time" to "time when needle is inserted")
- The time it takes to successfully identify the epidural space.(From "time when needle is inserted" to "time when epidural space is identified")