Pilot Study to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement

What this Trial Is About

Researchers are evaluating the BrightPoint Epidural device, a new system using multispectral reflectometry to help find the epidural space during lumbar neuraxial procedures. This device is being studied as a secondary confirmation tool alongside the traditional Loss of Resistance (LOR) method and as a training aid for anesthesiology trainees. The goal is to improve the standard care of epidural placement, which currently relies mainly on pressure-based techniques and can involve complications such as dural punctures and misplaced epidurals. Participants will undergo lumbar neuraxial procedures where trained anesthesiologists use the BrightPoint device connected between a standard epidural needle and a saline-filled LOR syringe. The device provides real-time visual feedback through color graphics and a display to confirm needle placement, supplementing the usual haptic feedback from the LOR technique. This observational study focuses on how well the device confirms epidural space access and its usefulness as a teaching tool. During the study, researchers will monitor the real-time confirmation of epidural space access, measure the time taken to insert the needle and identify the epidural space, and gather anesthesiologists' opinions on the device. They will also track the percentage of successful neuraxial procedures. Assessments occur after surgery completion, and participants may be monitored throughout the procedure. The study includes patients aged 18 to 99 undergoing lumbar neuraxial procedures requiring an epidural needle, with no upper limit on participation duration specified.

Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement