Neuraxial Ultrasound Device Study

NCT06281249 | Not Yet Recruiting FDA Device

• 1 other identifier: 73172
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Labor Pain; Cesarean Delivery Regional Anesthesia Induction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence of failed block

  30 minutes

• Incidence of post-dural puncture headache

  7 days

Study Arms (1)

Intrathecal neuraxial procedure

EXPERIMENTAL

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

Device: Ultrasound placement device

Interventions

Ultrasound placement device DEVICE

Device to assist in placement of epidural procedure

Also known as: Accuro 3S

Intrathecal neuraxial procedure

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• Rivanna Medical, Inc.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (8)

• 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.

  PMID: 33186303 BACKGROUND

• 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.

  PMID: 26580836 BACKGROUND

• 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.

  PMID: 33642943 BACKGROUND

• 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.

  PMID: 31920244 BACKGROUND

• 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.

  PMID: 34349368 BACKGROUND

• Cittadini G, Martinoli C. [Ultrasound and the bone: a difficult relationship]. Radiol Med. 1995 Jan-Feb;89(1-2):12-7. Italian.

  PMID: 7716291 BACKGROUND

• 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.

  PMID: 33452406 BACKGROUND

• 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.

  PMID: 28230717 BACKGROUND

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Clemens Ortner, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: February 20, 2024
• First Posted: February 28, 2024
• Study Start (Estimated): December 15, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)