Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement
ConditionLumbar Spine Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorHospital for Special Surgery, New York
About this trial
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.
Eligibility criteria
Qualifiers
Any patient undergoing a lumbar neuraxial procedure requiring epidural needle
Age 18-99
Disqualifiers
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
Trial design
Treatments tested in this trial
- Group 1 - Lumoptik BrightPoint Epidural Device
Treatment groups
36 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov