Lumoptik BRIGHTPOINT Reflectometer Device for Lumbar Epidural Placement

Lumbar Spine Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06020508
• Other study ID #: 2023-0074
• Status: Recruiting
• Start date: September 12, 2023
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Hospital for Special Surgery, New York
• Contact: Justas Lauzadis, PhD
• Phone: 212-774-2946
• Email: lauzadisj[@]hss.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

There have been few improvements to the LOR technique from a device standpoint in recent years, and those that options do exist have not achieved widespread clinical use. The devices that do exist are variations on pressure sensors, some automate the "resistance" by placing various systems in place to apply a pressure to the plunger so that it will inject when the epidural space is accessed without the practitioner doing it themselves. This concept is represented by devices such as the Epimatic syringe from Vygon. Others improve on this concept by monitoring the pressure required to inject a set volume of fluid, thus being able to differentiate between true and false losses, as during false losses the pressure will increase as more fluid is injected. This system is represented by the CompuFlo Device by Milestone Scientific.

The BrightPoint Epidural device is the first system that utilizes multispectral reflectometry in order to identify the epidural space. This technology has the theoretical benefit over pressure-based systems of being able to identify and differentiate between different issue types (muscle, ligament, bone) as the needle is advanced towards the epidural space. Lumoptik, the company behind the BrightPoint Epidural device, is an early-stage startup based in Cleveland, Ohio. The main questions this trial 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?

This trial is being conducted to improve our current standard of care in neuraxial placement of loss-of-resistance. While the loss of resistance technique is tried and true, especially in experienced hands, complications such as dural punctures, misplaced epidurals, patchy epidurals, neurologic injuries, and intravascular catheters can occur even in experienced hands. All of which can cause significant patient morbidity and costs to the healthcare system, and as is shown in the Lacombe attached, the effects of dural puncture can be long lived for the patient. There can also be a steep learning curve when learning the technique, with the frequency of inadvertent dural punctures significantly higher in the early stages of learning the procedure. Therefore, we as a specialty are obligated to evaluate potential improvements to our current way of practice to reduce the burden to our patients from the complications of our interventions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Any patient undergoing a lumbar neuraxial procedure requiring epidural needle

• Age 18-99

Exclusion Criteria:

• 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

• Tattoo at the site of epidural insertion

Related Conditions & MeSH terms

• Lumbar Spine Surgery

Intervention

Device:
• Group 1 - Lumoptik BrightPoint Epidural Device
Participants will undergo a neuraxial procedure to measure loss of resistance with saline in conjunction with the Lumoptik BrightPoint Epidural Device.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Lumoptik

Country where clinical trial is conducted

United States, 

References & Publications (2)

Eley VA, Abeypala W, Kelley A, Kumta N, Chin A. Recognized and unrecognized dural punctures in 12,981 labor epidurals: an audit of management. J Anesth. 2022 Jun;36(3):399-404. doi: 10.1007/s00540-022-03062-7. Epub 2022 Apr 27. — View Citation

Lacombe A, Downey K, Ye XY, Carvalho JCA. Long-term complications of unintentional dural puncture during labor epidural analgesia: a case-control study. Reg Anesth Pain Med. 2022 Jun;47(6):364-369. doi: 10.1136/rapm-2021-103266. Epub 2022 Mar 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Post-operation (after the surgery is complete)
Secondary	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.	Post-operation (after the surgery is complete)
Secondary	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?"	Post-operation (after the surgery is complete)
Secondary	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.	From "in OR time" to "time when needle is inserted"
Secondary	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.	From "time when needle is inserted" to "time when epidural space is identified"
Secondary	The percentage of Successful Neuraxial Procedures	The percentage of successful neuraxial procedures, calculated by dividing "the number successful neuraxial procedures placed without assistance or complication by the number of attempted neuraxial procedures"	Post-operation (after the surgery is complete)