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

Nerve Block Clinical Trial

Official title:

Comparison of Classical Ultrasound Guided Method and Combined Wearable Display Technology Method With Ultrasound in Interscalene Nerve Block Applied in Shoulder Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05409807
• Other study ID #: AIBU-TF-AR-II-002
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2023
• Source: Abant Izzet Baysal University
• Contact: Ilker Ital, MD
• Phone: (0374) 253 46 56
• Email: ilkerital[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block

Intervention

Device:
• Ultrasound guided smart glasses assisted
Ultrasound guided smart glasses assisted interscalene nerve block
• Ultrasound guided
Ultrasound guided interscalene nerve block

Locations

Country	Name	City	State
Turkey	Bolu Abant Izzet Baysal University Faculty of Medicine	Bolu

Sponsors (1)

Lead Sponsor	Collaborator
Abant Izzet Baysal University

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall attempt	Number of attempt of needling	During peripheral nerve block procedure. Not to exceed 20 minutes
Secondary	Ultrasound image time	From ultrasound probe application, to get nerves image on the ultrasound screen	During peripheral nerve block procedure. Not to exceed 20 minutes
Secondary	Nerve block time	From needle puncture, to local anesthetic spreading	During peripheral nerve block procedure. Not to exceed 20 minutes
Secondary	Overall success rate	The sensory and motor effect of the block	During peripheral nerve block procedure. Up to 1 day
Secondary	Operator's satisfaction	Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)	During peripheral nerve block procedure. Not to exceed 20 minutes
Secondary	Complication rate	Block failure, pneumothorax, hematoma, local anesthetic toxicity	Through study completion, an average of 2 week