Comparison of Classical Ultrasound Screen and Combined Wearable Display in Interscalene Nerve Blocks

NCT ID: NCT05409807

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2023-06-30

Brief Summary

This study hypothesizes that the use of smart glasses (Head-mounted display Vufine, model VUF-110, Vufine Inc., China)) improves the hand-eye coordination and the first-attempt success rate of ultrasound guided interscalene nerve block. This is a single-center, randomized, controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the interscalene block.

Detailed Description

Peripheral nerve blocks, which help patients to recover early after surgery, are performed safely and successfully under ultrasound guidance. Ultrasound-guided peripheral nerve blocks provide sufficient anesthesia for the operation alone or can be applied in combination with general anesthesia and provide postoperative analgesia.

Investigators encounter new developments in health technologies almost every day. With the development of smart technologies and the spread of wearable devices, their use in the field of health is increasing day by day.

Hand-eye coordination is an important skill, especially in the use of ultrasound. The inserted needle should be followed during the procedure in the appropriate area and safely delivered to the desired area.

Patients will be divided into either the study group or the control group. Interscalene nerve block will be performed with preoperative sedation, ultrasound guidance and nerve stimulator.

Interscalene nerve block will be applied to the patients in the study group by using the smart glasses screen, and to the patients in the control group with the conventional ultrasound screen.

In this clinical study, the first trial success rate of the procedures, the time spent during the procedure, the overall success rate, the ergonomics of the practitioner, and the complications related to the block will be recorded and compared.

Conditions

Nerve Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Classic Ultrasound Guided

Ultrasound guided interscalene nerve block

Group Type: EXPERIMENTAL

Ultrasound guided

Intervention Type: DEVICE

Ultrasound guided interscalene nerve block

Smart Glasses Assisted

Ultrasound guided smart glasses assisted interscalene nerve block

Group Type: EXPERIMENTAL

Ultrasound guided smart glasses assisted

Intervention Type: DEVICE

Ultrasound guided smart glasses assisted interscalene nerve block

Interventions

Ultrasound guided smart glasses assisted

Ultrasound guided smart glasses assisted interscalene nerve block

Intervention Type: DEVICE

Ultrasound guided

Ultrasound guided interscalene nerve block

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Patients who are planned to undergo surgery under general anesthesia
• Patients scheduled for postoperative analgesia after shoulder surgery

Exclusion Criteria

• Local anesthetic allergy
• Skin disease, infection, hematoma
• Chronic obstructive pulmonary disease
• Hepatic, renal, cardiac failures
• Pregnancy
• Uncooperative patient

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Ilker Ital

Assistan Professor Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ilker Ital, MD

Role: PRINCIPAL_INVESTIGATOR

Bolu Abant İzzet Baysal Medical School

Locations

Bolu Abant İzzet Baysal University Faculty of Medicine

Bolu, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ilker Ital, MD

Role: CONTACT

ilkerital@gmail.com

(0374) 253 46 56

Tacettin Ayanoglu, MD

Role: CONTACT

drtacettin@gmail.com

(0374) 253 46 56

Facility Contacts

Kasım İlker İtal, MD

Role: primary

ilkerital@gmail.com

+905337723300

Tacettin Ayanoglu, MD

Role: backup

ilkerital@gmail.com

+905312331970 ext. İtal

References

Yoon JW, Richter K, Vivas-Buitrago T, Kim EJ, Chen RE, Quinones-Hinojosa A, Diaz-Gomez JL, Clendenen SR. Technical Feasibility and Safety of Ultrasound-Guided Supraclavicular Nerve Block With Assistance of a Wearable Head-up Display. Reg Anesth Pain Med. 2018 Jul;43(5):559-561. doi: 10.1097/AAP.0000000000000803. No abstract available.

Reference Type: BACKGROUND

PMID: 29927851 (View on PubMed)

Przkora R, Mora J, Balduyeu P, Meroney M, Vasilopoulos T, Solanki D. Ultrasound-Guided Regional Anesthesia Using a Head-Mounted Video Display: A Randomized Clinical Study. Pain Physician. 2021 Jan;24(1):83-87.

Reference Type: BACKGROUND

PMID: 33400431 (View on PubMed)

Lim H, Kim MJ, Park JM, Kim KH, Park J, Shin DW, Kim H, Jeon W, Kim H, Kim J. Use of smart glasses for ultrasound-guided peripheral venous access: a randomized controlled pilot study. Clin Exp Emerg Med. 2019 Dec;6(4):356-361. doi: 10.15441/ceem.19.029. Epub 2019 Dec 31.

Reference Type: BACKGROUND

PMID: 31910508 (View on PubMed)

Jang YE, Cho SA, Ji SH, Kim EH, Lee JH, Kim HS, Kim JT. Smart Glasses for Radial Arterial Catheterization in Pediatric Patients: A Randomized Clinical Trial. Anesthesiology. 2021 Oct 1;135(4):612-620. doi: 10.1097/ALN.0000000000003914.

Reference Type: BACKGROUND

PMID: 34352073 (View on PubMed)

Kasuya Y, Moriwaki S, Inano C, Fukada T, Komatsu R, Ozaki M. Feasibility of the head-mounted display for ultrasound-guided nerve blocks: a pilot simulator study. J Anesth. 2017 Oct;31(5):782-784. doi: 10.1007/s00540-017-2371-x. Epub 2017 May 5.

Reference Type: BACKGROUND

PMID: 28477229 (View on PubMed)

Other Identifiers

AIBU-TF-AR-II-002

Identifier Type: -

Identifier Source: org_study_id