BrightPoint Reflectometer Device Study

University Hospitals (UH)

Status: Completed

Conditions: Epidural Placement

Treatments: Device: BrightPoint

Study type: Interventional

Funder types: Other

Identifiers

NCT05616299

STUDY20220677

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: Female

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 2 patient groups

BrightPoint Epidural

Experimental group

Description:

Subjects will receive an epidural using the BrightPoint device concurrent with usual LOR technique using the same epidural needle, sterile saline, syringe, etc.

Treatment:

Device: BrightPoint

Normal Epidural

No Intervention group

Description:

Subjects will have an epidural placed in usual manner with LOR technique using the same epidural needle, sterile saline, syringe etc. but without use of the BrightPoint device.