Pilot Study for Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement
Hospital for Special Surgery, New York
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: 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.
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 s…
Eligibility
- Age range
- 18–99 years
- Sex
- All
- Healthy volunteers
- Yes
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
Interventions
- DeviceGroup 1 - Lumoptik BrightPoint Epidural Device
Participants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.
Location
- Hospital for Special SurgeryNew York, New York