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

NCT ID: NCT02442973

Last Updated: 2022-03-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2018-01-12

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Control group (CG):

Standard practice group

Control group (CG): standard practice

Intervention Type: PROCEDURE

Standard practice group

Ultrasound group (UG):

SpineView3D™ anatomical "scouting" approach

Ultrasound group (UG):

Intervention Type: PROCEDURE

SpineView3D™ anatomical "scouting" approach

Accuro SpineView3D™

Intervention Type: DEVICE

subject will be scanned with 'Accuro SpineView3D

Interventions

Control group (CG): standard practice

Standard practice group

Intervention Type: PROCEDURE

Ultrasound group (UG):

SpineView3D™ anatomical "scouting" approach

Intervention Type: PROCEDURE

Accuro SpineView3D™

subject will be scanned with 'Accuro SpineView3D

Intervention Type: DEVICE

Other Intervention Names

CG; UG; scan

Eligibility Criteria

Inclusion Criteria

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

• ASA-1 and ASA-2
• BMI > 30

Exclusion Criteria

Patients with known spinal deformities allergies to ultrasound gel

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Rivanna Medical, LLC

UNKNOWN

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Tiouririne, MD

UVA Anesthesiology Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed Tiouririne, MD

Role: PRINCIPAL_INVESTIGATOR

UVA Health System

Locations

University of Virginia Health System

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21572316 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20696564 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11421838 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14656785 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21422997 (View on PubMed)

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

Reference Type: BACKGROUND

Other Identifiers

Rivanna Clin-002

Identifier Type: -

Identifier Source: org_study_id