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
This trial accepts healthy volunteersQualifiers
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 population
Patients scheduled to have surgery at the Hospital for Special Surgery that will require a lumbar neuraxial procedure requiring an epidural needle.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Group 1 - Lumoptik BrightPoint Epidural Device
DeviceParticipants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.
Treatment groups
36 Participants
are divided into 1 treatment groupGroup A: Group 11 intervention
Trial outcomes
Primary outcomes
1
Real time confirmation of epidural space with loss of resistance technique
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).
Time frame
Post-operation (after the surgery is complete)Secondary outcomes
1
Clinical (anesthesiologist) opinions on Lumoptik Bright Point Epidural device
On the post-procedure questionnaire, the anesthesiologist will give their opinion about the device following their use of the study device.
Time frame
Post-operation (after the surgery is complete)2
Color graphics aid in the identification of needle tips.
On the post-procedure questionnaire, the proceduralist will give a yes or no answer to the prompt to the question "Did the Bright Point Epidural color graphic improve your understanding of where your needle tip is or what tissue it is in?"
Time frame
Post-operation (after the surgery is complete)3
The time it takes to insert the epidural needle into the patient's skin.
The time between when the patient entered the operating room and when the epidural needle was inserted into the patient's skin.
Time frame
From "in OR time" to "time when needle is inserted"4
The time it takes to successfully identify the epidural space.
The time between inserting an epidural needle into the skin and successfully identifying the epidural space.
Time frame
From "time when needle is inserted" to "time when epidural space is identified"Sponsors and contacts
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Source ClinicalTrials.gov