Validation of Educational Effect of Nerve Tracking Function Mounted on the Ultrasound

Healthy Clinical Trial

Official title:

Validation of Educational Effect of Nerve Tracking Function Mounted on the Ultrasound: A Randomized Comparative Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05857787
• Other study ID #: 2023-161-1416
• Status: Recruiting
• Phase: N/A
• Start date: July 12, 2023
• Est. completion date: June 10, 2024

Study information

• Verified date: August 2023
• Source: Seoul National University
• Contact: Jee Youn Moon, MD, PhD
• Phone: 821052992036
• Email: jymoon0901[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

2nd, 3rd, 4th year medical school students and 1st, 2nd, 3rd year residents of anesthesiology who voluntarily signed a consent form for participation in the study are investigated for the history of previous ultrasound use and other details of the subjects before the lecture and ultrasound practice.

Well-trained pain physicians provides anatomical education on the brachial plexus supraclavicular level and the median nerve at wrist level. At this time, an ultrasound cross-sectional image of the corresponding nerve is provided. After anatomical education, research subjects (students and residents) are randomly assigned to group A or B after receiving basic education in a 1:1 ratio.

Subjects receive training for about 10 minutes to find the brachial plexus (supraclavicular level) and median nerve (carpal tunnel level) through a live demo method that directly uses ultrasound. At this time, group A receives training in the live demo method with the nerve track function, and group B receives training in the live demo method without the nerve track function.

After a 5-minute intermission, both groups A and B were asked to find the brachial plexux and median nerve without the nerve track function in the instructor's left upper limb. Each nerve is to be found within 5 minutes, and it is considered a failure after 5 minutes.

After activating the nerve track function in both groups without intermission, the educator shows the nerves corresponding to the brachial plexus at supracalvicualr level and median nerve at wrist level in the left upper limb, and conducts the same 5-minute training on finding them.

After a 5-minute intermission, with the nerve track function turned off again, ask the educator to find the brachial plexus and median nerve in the right arm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 10, 2024
• Est. primary completion date: April 23, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 2nd, 3rd, 4th year students at Seoul National University College of Medicine

• 1st, 2nd, 3rd year residents of anesthesiology at Seoul National University Hospital

• Those who voluntarily consented

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• Ultrasound with nerve track function
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.
• Ultrasound without nerve track function
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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University

Country where clinical trial is conducted

Korea, Republic of, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Success rate (%) of accurately locating a nerve in the second round in groups A and B	After completing a first round of finding nerves, the subjects are trained using the nerve track function common to both groups, and are then asked to find nerves again. It is considered a success if each nerve is found within 5 minutes.	5 minutes after starting to find the nerve using ultrasound
Secondary	Subjects' assessment of the educational effect of the nerve track function	After completing all the procedures, the subjects expressed their satisfaction with the educational effect of nerve track function on a 5-point Likert scale. Participants will be asked to use a 5-point Likert scale, ranging from 1 to 5, for their responses. Regarding the assessment of nerve track function, the scale is explained as follows: 1 point representing "not at all helpful", 2 point representing "slightly helpful", 3 point representing "neutral", 4 point representing "somewhat helpful", and 5 point representing "very helpful".	5 minutes after the second round of finding nerves
Secondary	Medical students and anesthesiology residents success rate (%)	Among the subjects, the success rate was calculated by dividing the students of the medical school and the residents of the department of anesthesiology. Similarly, finding a nerve within 5 minutes is considered a success. Each round is calculated separately.	5 minutes after starting to find the nerve using ultrasound at first round and second round