Neuraxial Ultrasound Device Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-04-01

Study Completion Date

2025-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the study is to develop a device that can eliminate failed neuraxial placements in challenging patients.The study will attempt to improve safety and efficacy of neuraxial anesthesia with high precision real-time needle visualization through automated real-time needle guidance at the bedside with an experimental device (Accuro 3S). Investigators will verify the clinical workflow for utilizing the Accuro 3S during epidural and spinal procedures and validation of needle visualization while using the device as well as anatomical guidance provided by the device during spinal imaging.The underlying bone imaging enhancement algorithms were introduced in the commercially available FDA approved Accuro. The Accuro 3S will be used to establish needle insertion point and trajectory, after which the clinician will use standard of care methods to advance the needle such as the loss of resistance method.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

NAPS: Non-awake Versus Awake Placement of Spinal Cord Stimulators

NCT02284542

Chronic Pain Sciatica Failed Back Surgery Syndrome

COMPLETED

Real-Time Monitoring of the Injection Pressure During the Peripheral Nerve Block

NCT07302997

No Condition Real-time Monitoring of the Injection Pressure During Ultrasound-guided Axillary Block

RECRUITING NA

Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.

NCT07288411

TMD Temporomandibular Disorders (TMDs)

NOT_YET_RECRUITING NA

Effect of Transauricular Vagal Stimulation on Cardiac Function After Spinal Cord Injury

NCT07007884

Spinal Cord Injury (SCI)

RECRUITING NA

Auricular Vagus Nerve Stimulation (aVNS) in Chronic Spinal Cord Injuries (SCI)

NCT06588608

Spinal Cord Injuries

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective, structured observational study (data collection study) in which Investigators enroll patients who are scheduled for neuraxial anesthesia procedures.

Qualified subjects will be identified and contacted by the anesthesia team prior to their clinical evaluation for labor neuraxial analgesia. Potential patients will be informed of the study, and if study individuals choose to participate and an informed consent form will be signed prior to any study related activities.

When study participants request labor analgesia, investigators will incorporate routine care delivery flow for patients receiving ultrasound guided neuraxial anesthesia.

The clinician will apply ultrasound gel to the Accuro 3S probe (gel inside the probe need not be sterile), and then cover the probe in a sterile probe cover. Sterile ultrasound gel will then be applied to the patient's skin on the back to enable imaging. The Accuro 3S probe will be applied to the patient's spinal region and the clinician will perform scouting scans. Image recordings can be captured by depressing a button located on the probe handle. While performing the scouting scans, the provider will take several image recordings of the spine. The image recordings will include two levels, finding the space, and then at each level plus a spinous process, scanning left and right at each of these points.

The clinician will then administer local anesthetic prior to needle procedures. After needle insertion point and trajectory is established on the ultrasound image, the epidural or spinal needle will then be advanced by the clinician based on their standard technique. While advancing the needle the provider will collect a series of image recordings.

After proper placement of needle/catheter, the Accuro 3S device will then be removed from the patient and they will proceed with standard clinical protocol for post placement care.

Accuro 3S: Primary data collected during this study will be images recordings captured during the scouting and needle placement for the epidural procedure. Images will be acquired directly on the 3S and will not contain patient identifiers.

After collection of data up to 100 patients, Investigators will be moving to clinical analysis.

Rivanna is the sponsor and will be funding this research. The de-identified patient data that Rivanna will receive for analysis include: results of demographic information (e.g. age, height, weight, sex, race, and ethnicity). Obstetric details including gravity, parity, gestational age, labor or cesarean delivery, pain score prior to and after placement. Accuro 3S Images (including scouting images of spine and images of needle placement). Insertion: Number of needle passes and redirects, interspace attempted/inserted; epidural or spinal, and needle gauges used. Number, type, and details of any complication (e.g. wet tap). Failed spinal or epidural including: pain \>3/10 after labor epidural, catheter replacement, no or one-sided sensory block, failure to provide cesarean anesthesia, conversion to different type of anesthesia.

Patients will undergo their standard medical and obstetric treatment at the discretion of the obstetrical and anesthesia team. There will be no delay in their treatment due to this study, and the device data will not be available of influence care.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Labor Pain Cesarean Delivery Regional Anesthesia Induction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intrathecal neuraxial procedure

Participants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device.

Group Type EXPERIMENTAL

Ultrasound placement device

Intervention Type DEVICE

Device to assist in placement of epidural procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ultrasound placement device

Device to assist in placement of epidural procedure

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Accuro 3S

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 18 years or older
* The patient is eligible for placement of neuraxial anesthesia, and the patient has agreed to the procedure.
* Patient skin is intact in the area of placement of the epidural or spinal anesthesia.

Exclusion Criteria

* Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myeloopticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (INR greater than 1.3 not on Coumadin or PTT greater than 42), platelets less than 70,000/μL, or evidence of infection at potential epidural site.
* Presence of orthopedic implants in the spine.
* Skin dyscrasias or allergies to the ultrasound procedure.
* Unable to assume sitting position.
* Body Mass Index (BMI) less than 20 kg/m2.
* Known allergies to ultrasound gel.
* Known history of allergic reactions to adhesives used in standard epidural placement

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No