NCT06281249

Neuraxial Ultrasound Device Study

Real-time Spine Ultrasound Imaging System: Data Collection Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Stanford University · Academic / Other
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

• Labor Pain
• Cesarean Delivery Regional Anesthesia Induction

Interventions

Type	Name	Description
DEVICE	Ultrasound placement device	Device to assist in placement of epidural procedure

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2024-02-28
• Last updated: 2024-03-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study