NCT05409807

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.

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

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

May 8, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 8, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 6, 2023

Status Verified

May 1, 2023

Enrollment Period

5 months

First QC Date

May 8, 2022

Last Update Submit

May 4, 2023

Conditions

Nerve Block

Keywords

Interscalene BlockSmart GlassesWearable Technology

Outcome Measures

Primary Outcomes (1)

  • First attempt success rate

    Ultrasound visualization and neurostimulator confirmation of the nerve plexus sheath being reached

    During peripheral nerve block procedure. Not to exceed 20 minutes

Secondary Outcomes (6)

  • Overall attempt

    During peripheral nerve block procedure. Not to exceed 20 minutes

  • Ultrasound image time

    During peripheral nerve block procedure. Not to exceed 20 minutes

  • Nerve block time

    During peripheral nerve block procedure. Not to exceed 20 minutes

  • Overall success rate

    During peripheral nerve block procedure. Up to 1 day

  • Operator's satisfaction

    During peripheral nerve block procedure. Not to exceed 20 minutes

  • +1 more secondary outcomes

Study Arms (2)

Classic Ultrasound Guided

EXPERIMENTAL

Ultrasound guided interscalene nerve block

Device: Ultrasound guided

Smart Glasses Assisted

EXPERIMENTAL

Ultrasound guided smart glasses assisted interscalene nerve block

Device: Ultrasound guided smart glasses assisted

Interventions

Ultrasound guided smart glasses assistedDEVICE

Ultrasound guided smart glasses assisted interscalene nerve block

Smart Glasses Assisted
Ultrasound guidedDEVICE

Ultrasound guided interscalene nerve block

Classic Ultrasound Guided

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bolu Abant İzzet Baysal University Faculty of Medicine

Bolu, 14030, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

    PMID: 29927851BACKGROUND

  • 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.

    PMID: 33400431BACKGROUND

  • 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.

    PMID: 31910508BACKGROUND

  • 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.

    PMID: 34352073BACKGROUND

  • 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.

    PMID: 28477229BACKGROUND

Study Officials

  • Ilker Ital, MD

    Bolu Abant İzzet Baysal Medical School

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilker Ital, MD

CONTACT

(0374) 253 46 56ilkerital@gmail.com

Tacettin Ayanoglu, MD

CONTACT

(0374) 253 46 56drtacettin@gmail.com

Study Design

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

Study Record Dates

First Submitted

May 8, 2022

First Posted

June 8, 2022

Study Start

January 30, 2023

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

May 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)