Handheld 3D Lumbar Spine Navigation: A Clinical Validation Study RM002

NCT02442973 | Completed

• 1 other identifier: Rivanna Clin-002
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, at UVA, handheld ultrasound devices (like those used to view an unborn baby) are only two dimensional. The Accuro is a three dimensional handheld ultrasound device. This device uses sound waves to create pictures of the spine in three dimensions. This may allow the physician to view the spine in more detail for procedures such as spinal anesthesia and other diagnostic procedures. Epidural analgesia is the mainstay procedure for the management of labor pain. The precise placement of a needle or catheter in proximity to landmarks of the spinal bone anatomy is required for the procedure to succeed. The current standard of care is called the 'blind approach' (i.e. without medical imaging) and involves a physician manually palpating a patient's back to locate spinal bone landmarks. The needle is then inserted with respect to the location of the landmarks and inserted until a loss-of-resistance is manually detected. This approach, while most common, has been associated with success rates as low as 68% in obese patients (2). Alternative methods have been investigated for this problem, including ultrasound (US) guidance, which offers real-time imaging. Several studies have demonstrated ultrasound's efficacy for spinal anesthesia (1-6). However, standard US systems are engineered to image soft tissue rather than bone structures, with the consequence that bone is imaged poorly. US images are often degraded by a number of noise sources including speckle noise, reverberations and off-axis scattering, particularly when bone is present, making visualization of bone anatomy features difficult. Moreover, arranging access to ultrasound for the purpose of spinal anesthesia alone is cumbersome. Thus, the efficacy of guided spinal anesthesia and diagnostic procedures using standard ultrasound systems is limited and the benefits that it offers are heavily dependent on the user's familiarity and skill with ultrasonography (4). Recently, new medical imaging technologies have been developed at Rivanna Medical, LLC to address the significant clinical need for technological advances that improve the placement of spinal anesthesia, epidural analgesia and other diagnostic procedures. The Accuro is a pocket-sized and battery operated ultrasound instrument that incorporates new signal processing-based technologies for enhanced bone imaging including 3D navigation of the lumbar spine. The device is a single self-contained unit consisting of an ultrasound system, ultrasound probe, and rotatable touchscreen display. The instrument enables a SpineView3D™ technology to facilitate spinal anesthesia guidance with real-time 3D navigation of the lumbar spine anatomy. SpineView3D™ technology facilitates image interpretation of individual 2D lumbar spine scans by automating spinal bone landmark detection and depth measurements and providing a real-time assessment of scan plane orientation in 3D. SpineView3D™ makes image interpretation and measurements of the lumbar spine anatomy simple, quick, and easy. Real-time 2D scans from either SpineView3D™ or general-purpose bone presets are formed using patent-pending BoneEnhance+™ technology. The BoneEnhance+™ technology provides images of bone anatomy at greater bone-to-tissue contrast compared with conventional ultrasound image reconstructions.

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

• Success rates:

  defined as successful epidural administration on the first needle insertion attempt.

  1 day

Study Arms (2)

Control group (CG):

Standard practice group

Procedure: Control group (CG): standard practice

Ultrasound group (UG):

SpineView3D™ anatomical "scouting" approach

Procedure: Ultrasound group (UG):; Device: Accuro SpineView3D™

Interventions

Control group (CG): standard practice PROCEDURE

Standard practice group

Also known as: CG

Control group (CG):

Ultrasound group (UG): PROCEDURE

SpineView3D™ anatomical "scouting" approach

Also known as: UG

Ultrasound group (UG):

Accuro SpineView3D™ DEVICE

subject will be scanned with 'Accuro SpineView3D

Also known as: scan

Ultrasound group (UG):

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients between the ages of 18 and 40 presenting for delivery and planning epidural anesthesia.

You may qualify if:

• Patients between the ages of 18 and 40 presenting for delivery and planning epidural anesthesia
• ASA-1 and ASA-2
• BMI \> 30

You may not qualify if:

• Patients with known spinal deformities allergies to ultrasound gel

Sponsors & Collaborators

• University of Virginia: lead
• Rivanna Medical, LLC: collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (6)

• Chin KJ, Perlas A, Chan V, Brown-Shreves D, Koshkin A, Vaishnav V. Ultrasound imaging facilitates spinal anesthesia in adults with difficult surface anatomic landmarks. Anesthesiology. 2011 Jul;115(1):94-101. doi: 10.1097/ALN.0b013e31821a8ad4.

  PMID: 21572316 BACKGROUND

• Vallejo MC, Phelps AL, Singh S, Orebaugh SL, Sah N. Ultrasound decreases the failed labor epidural rate in resident trainees. Int J Obstet Anesth. 2010 Oct;19(4):373-8. doi: 10.1016/j.ijoa.2010.04.002. Epub 2010 Aug 8.

  PMID: 20696564 BACKGROUND

• Grau T, Leipold RW, Conradi R, Martin E. Ultrasound control for presumed difficult epidural puncture. Acta Anaesthesiol Scand. 2001 Jul;45(6):766-71. doi: 10.1034/j.1399-6576.2001.045006766.x.

  PMID: 11421838 BACKGROUND

• Grau T, Bartusseck E, Conradi R, Martin E, Motsch J. Ultrasound imaging improves learning curves in obstetric epidural anesthesia: a preliminary study. Can J Anaesth. 2003 Dec;50(10):1047-50. doi: 10.1007/BF03018371.

  PMID: 14656785 BACKGROUND

• Chin KJ, Karmakar MK, Peng P. Ultrasonography of the adult thoracic and lumbar spine for central neuraxial blockade. Anesthesiology. 2011 Jun;114(6):1459-85. doi: 10.1097/ALN.0b013e318210f9f8.

  PMID: 21422997 BACKGROUND

• Karmakar MK. Ultrasound for central neuroaxial blocks. Techniques in regional anesthesia and pain management 2009;13:161-70.

  BACKGROUND

MeSH Terms

Interventions

Control Groups; Radionuclide Imaging

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Radioisotope

Study Officials

• Mohammed Tiouririne, MD

  UVA Health System

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: UVA Anesthesiology Faculty

Study Record Dates

• First Submitted: May 8, 2015
• First Posted: May 13, 2015
• Study Start: February 1, 2016
• Primary Completion: January 12, 2018
• Study Completion: January 12, 2018
• Last Updated: March 10, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)