NCT05857787

Brief Summary

The purpose of this study is to find out whether the nerve track function is helpful in distinguishing appropriate anatomical structures for beginners using ultrasound.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

July 12, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 23, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 10, 2024

Completed
Last Updated

August 7, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

April 23, 2023

Last Update Submit

August 3, 2023

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Success rate (%) of accurately locating a nerve in the first round in groups A and B

    The subjects search for the median nerve and brachial plexus after ultrasound live demo training according to the group. If each nerve is found within 5 minutes, it is considered a success.

    5 minutes after starting to find the nerve using ultrasound

Secondary Outcomes (3)

  • Success rate (%) of accurately locating a nerve in the second round in groups A and B

    5 minutes after starting to find the nerve using ultrasound

  • Subjects' assessment of the educational effect of the nerve track function

    5 minutes after the second round of finding nerves

  • Medical students and anesthesiology residents success rate (%)

    5 minutes after starting to find the nerve using ultrasound at first round and second round

Study Arms (2)

With nerve track function(group A)

ACTIVE COMPARATOR

trained in the live demo method with nerve track function

Device: Ultrasound with nerve track function

Without nerve track function(group B)

ACTIVE COMPARATOR

trained in the existing live demo method without nerve track function

Device: Ultrasound without nerve track function

Interventions

Ultrasound with nerve track functionDEVICE

The nerve track function installed in some ultrasound devices is software that accumulates ultrasound data obtained from humans and uses ultrasound to identify the target nerve through deep learning. Well-trained pain physicians use this feature to educate subjects before seeking brachial plexus and median nerve.

With nerve track function(group A)
Ultrasound without nerve track functionDEVICE

The nerve track function installed in some ultrasound devices is software that accumulates ultrasound data obtained from humans and uses ultrasound to identify the target nerve through deep learning. Well-trained pain physicians use ultrasound alone without this feature to educate subjects before seeking brachial plexus and median nerve.

Without nerve track function(group B)

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nd, 3rd, 4th year students at Seoul National University College of Medicine
  • st, 2nd, 3rd year residents of anesthesiology at Seoul National University Hospital
  • Those who voluntarily consented

You may not qualify if:

  • Those who have previously identified the brachial plexus at supraclavicular level and median nerve at wrist level using ultrasound

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

RECRUITING

Related Publications (7)

  • Bhatia A, Brull R. Review article: is ultrasound guidance advantageous for interventional pain management? A systematic review of chronic pain outcomes. Anesth Analg. 2013 Jul;117(1):236-51. doi: 10.1213/ANE.0b013e31828f5ee4. Epub 2013 Apr 16.

    PMID: 23592606BACKGROUND

  • Narouze SN, Provenzano D, Peng P, Eichenberger U, Lee SC, Nicholls B, Moriggl B; American Society of Regional Anesthesia and Pain Medicine; European Society of Regional Anaesthesia and Pain Therapy; Asian Australasian Federation of Pain Societies. The American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, and the Asian Australasian Federation of Pain Societies Joint Committee recommendations for education and training in ultrasound-guided interventional pain procedures. Reg Anesth Pain Med. 2012 Nov-Dec;37(6):657-64. doi: 10.1097/AAP.0b013e318269c189.

    PMID: 23080347BACKGROUND

  • Bodenham AR. Editorial II: Ultrasound imaging by anaesthetists: training and accreditation issues. Br J Anaesth. 2006 Apr;96(4):414-7. doi: 10.1093/bja/ael032. No abstract available.

    PMID: 16549625BACKGROUND

  • Mendiratta-Lala M, Williams T, de Quadros N, Bonnett J, Mendiratta V. The use of a simulation center to improve resident proficiency in performing ultrasound-guided procedures. Acad Radiol. 2010 Apr;17(4):535-40. doi: 10.1016/j.acra.2009.11.010. Epub 2010 Jan 25.

    PMID: 20097583BACKGROUND

  • Kwon SY, Hong SH, Kim ES, Park HJ, You Y, Kim YH. The Efficacy of Lumbosacral Spine Phantom to Improve Resident Proficiency in Performing Ultrasound-Guided Spinal Procedure. Pain Med. 2015 Dec;16(12):2284-91. doi: 10.1111/pme.12870. Epub 2015 Aug 3.

    PMID: 26234900BACKGROUND

  • van Eerd M, Patijn J, Sieben JM, Sommer M, Van Zundert J, van Kleef M, Lataster A. Ultrasonography of the cervical spine: an in vitro anatomical validation model. Anesthesiology. 2014 Jan;120(1):86-96. doi: 10.1097/ALN.0000000000000006.

    PMID: 24141229BACKGROUND

  • McVicar J, Niazi AU, Murgatroyd H, Chin KJ, Chan VW. Novice performance of ultrasound-guided needling skills: effect of a needle guidance system. Reg Anesth Pain Med. 2015 Mar-Apr;40(2):150-3. doi: 10.1097/AAP.0000000000000209.

    PMID: 25642909BACKGROUND

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Jee Youn Moon, MD, PhD

    Seoul National University Hospital

    STUDY DIRECTOR

Central Study Contacts

Jee Youn Moon, MD, PhD

CONTACT

821052992036jymoon0901@gmail.com

Jeongsoo Kim, MD

CONTACT

821047346422dreamsu457@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 23, 2023

First Posted

May 15, 2023

Study Start

July 12, 2023

Primary Completion

April 23, 2024

Study Completion

June 10, 2024

Last Updated

August 7, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)