Neuraxial Ultrasound Device Study

Real-time Spine Ultrasound Imaging System: Data Collection Study

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Labor Pain; Cesarean Delivery Regional Anesthesia Induction
• Intervention / Treatment: Device: Ultrasound placement device

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intrathecal neuraxial procedure; Participants undergoing surgery, receiving neuraxial intrathecal anesthesia with block placement in part by the investigational device.	Device: Ultrasound placement device; Device to assist in placement of epidural procedure; Other Names: Accuro 3S

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of difficult block placement	Difficult block placement is defined by need of > 2 needle insertion attempts for succesful neuraxial analgesia/anesthesia	15 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of failed block	Failed labor epidural analgesia and spinal anesthesia will be defined by presence of 1 or more of the following conditions: one-sided or no sensory block, pain >3/10 after epidural placement, epidural replacement, conversion to a different form of anesthesia)	30 minutes
Incidence of post-dural puncture headache	Headache developing within 7 days post block placement defined by presence of at least one of the following symptoms: posture dependent headache, symmetric headache posture dependent, neck pain posture dependent	7 days

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: Rivanna Medical, Inc.
• Investigators: Principal Investigator: Clemens Ortner, MD, Stanford University

Publications and helpful links

General Publications

• Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
• Ring L, Landau R, Delgado C. The Current Role of General Anesthesia for Cesarean Delivery. Curr Anesthesiol Rep. 2021;11(1):18-27. doi: 10.1007/s40140-021-00437-6. Epub 2021 Feb 24.
• Boselli E, Hopkins P, Lamperti M, Estebe JP, Fuzier R, Biasucci DG, Disma N, Pittiruti M, Traskaite V, Macas A, Breschan C, Vailati D, Subert M. European Society of Anaesthesiology and Intensive Care Guidelines on peri-operative use of ultrasound for regional anaesthesia (PERSEUS regional anesthesia): Peripheral nerves blocks and neuraxial anaesthesia. Eur J Anaesthesiol. 2021 Mar 1;38(3):219-250. doi: 10.1097/EJA.0000000000001383.
• Rajagopalan S, Shah K, Guffey D, Tran C, Suresh M, Wali A. Predictors of difficult epidural placement in pregnant women: A trainees' perspective. J Anaesthesiol Clin Pharmacol. 2019 Oct-Dec;35(4):548-552. doi: 10.4103/joacp.JOACP_340_18.
• Ismail S, Raza A, Munshi K, Tabassum R. Failure rate of labor epidural: An observational study among different levels of trainee anesthesiologists in a university hospital of a developing country. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):210-215. doi: 10.4103/joacp.JOACP_39_19. Epub 2021 Jul 15.
• Cittadini G, Martinoli C. [Ultrasound and the bone: a difficult relationship]. Radiol Med. 1995 Jan-Feb;89(1-2):12-7. Italian.
• Mao Q, He H, Lu Y, Hu Y, Wang Z, Gan M, Yan H, Chen L. Ultrasound probe tilt impedes the needle-beam alignment during the ultrasound-guided procedures. Sci Rep. 2021 Jan 15;11(1):1599. doi: 10.1038/s41598-021-81354-w.
• Tiouririne M, Dixon AJ, Mauldin FW Jr, Scalzo D, Krishnaraj A. Imaging Performance of a Handheld Ultrasound System With Real-Time Computer-Aided Detection of Lumbar Spine Anatomy: A Feasibility Study. Invest Radiol. 2017 Aug;52(8):447-455. doi: 10.1097/RLI.0000000000000361.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: February 20, 2024
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 73172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No