Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Hospital for Special Surgery (HSS)

Status: Enrolling

Conditions: Lumbar Spine Surgery

Treatments: Device: Group 1 - Lumoptik BrightPoint Epidural Device

Study type: Observational

Funder types: Other

Identifiers

NCT06020508

2023-0074

Details and patient eligibility

About

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:

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?

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

36 participants in 1 patient group

Group 1

Description:

Attending anesthesiologists who are trained in epidural placement will perform neuraxial procedures (CSEs, Epidural, Spinals through an epidural needle) utilizing loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device. The Lumoptik device will be connected between a standard commercially available 17G or 18G, 3.5-inch epidural needle and a saline filled loss of resistance syringe. The anesthesiologist will view the Lumoptik BrightPoint visual display in real time as the epidural procedures are performed. The LOR epidural procedure using haptic feedback will be used as the primary confirmation of correct needle placement in the epidural space. Graphic and color circle information from the Lumoptik visual display will be used as a secondary confirmation of epidural placement.

Treatment:

Device: Group 1 - Lumoptik BrightPoint Epidural Device