Clinical trial NCT05616299: BrightPoint Reflectometer Device Study
Official title: Human Clinical Trial to Evaluate the BRIGHTPOINT Reflectometer Device as Secondary Confirmation to Loss of Resistance in Lumbar Epidural Placement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epidural Placement
Keywords: Labor
Epidural
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: Lumoptik, Inc.
First posted: 2022-11-15
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Participants are being asked to participate in this study because they are having an epidural placed for labor. This human clinical trial has been designed to evaluate the use of the BrightPoint Reflectometer Device (AKA BrightPoint device) as secondary confirmation of Loss of Residence (LOR) for lumbar epidural placement by an experienced clinician. For this study, participants will be randomized to receive an epidural by an experienced clinician either with or without the use of the BrightPoint device. Epidurals performed as a part of this study will be done in a manner similar to how epidurals are currently performed in the hospital. The epidural space will be entered using usual loss of resistance technique for all patients. If the BrightPoint device is used, it will be as secondary verification of entry into the epidural space.


Eligibility criteria: Inclusion Criteria:

* Any patient undergoing an epidural procedure

Exclusion Criteria:

* Previous lumbar spine surgery
* Any known spinal abnormality that would interferre with successfully advancing a needle into the epidural space
* Any subject that requires an epidural needle longer than 4.0 inches
* Any procedure requiring use of CSE needles
* Any contraindication to neuraxial anesthesia
* No subjects in advanced active labor, e.g., 6-8 cm dilated
* Tattoo at the site of epidural insertion

Primary outcomes:
measure: Number of times the BrightPoint device was able to measure Loss of Residence (LOR) accurately.
timeFrame: Up to 90 minutes
Secondary outcomes:
measure: Number of times epidural accessed while using BrightPoint device as measured by clinical log
timeFrame: Up to 90 minutes
measure: Number of times epidural catheter was used during the procedure as measured by clinical log
timeFrame: Up to 20 minutes
measure: Number of adverse events as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times the BrightPoint device provided real-time secondary confirmation of Loss of Residence (LOR) as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times the BrightPoint device provided beneficial qualitative/quantitative clinical information to help complete the epidural as measured by clinician log.
timeFrame: Up to 90 minutes
measure: Number of times clinician experienced the haptic feel of entering the ligamentum flavum (LF) as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times clinician experienced LOR after entering the epidural space as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times clinician experienced the haptic sensation of the needle contacting any tissue that was not expected as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times there were issues with catheterization as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times there were issues achieving pain management as measured by clinician log
timeFrame: Up to 4 hours
measure: Number of times the device indicated the needle tip was entering the LF as measured by clinician log
timeFrame: Up to 20 minutes
measure: Number of times the device showed a significant change of color from the light in LF to the dark in ES as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times the device showed a significant change of reflectance from high in LF to low in ES as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times the LOR and BrightPoint device agreed as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times coring was observed during procedure as measured by clinician log
timeFrame: Up to 90 minutes
measure: Number of times the BrightPoint interfered with the ability to perform the epidural placement in the usual manner with LOR and haptic feedback as measured by clinician log
timeFrame: Up to 90 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Lora Levin, MD
role: PRINCIPAL_INVESTIGATOR
References: