Clinical trial NCT05409807: Comparison of Classical Ultrasound Screen and Combined Wearable Display in Interscalene Nerve Blocks
Official title: Comparison of Classical Ultrasound Guided Method and Combined Wearable Display Technology Method With Ultrasound in Interscalene Nerve Block Applied in Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nerve Block
Keywords: Interscalene Block
Smart Glasses
Wearable Technology
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: First attempt success rate
timeFrame: During peripheral nerve block procedure. Not to exceed 20 minutes
Secondary outcomes:
measure: Overall attempt
timeFrame: During peripheral nerve block procedure. Not to exceed 20 minutes
measure: Ultrasound image time
timeFrame: During peripheral nerve block procedure. Not to exceed 20 minutes
measure: Nerve block time
timeFrame: During peripheral nerve block procedure. Not to exceed 20 minutes
measure: Overall success rate
timeFrame: During peripheral nerve block procedure. Up to 1 day
measure: Operator's satisfaction
timeFrame: During peripheral nerve block procedure. Not to exceed 20 minutes
measure: Complication rate
timeFrame: Through study completion, an average of 2 week
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant İzzet Baysal University Faculty of Medicine
Study officials:
affiliation: Bolu Abant İzzet Baysal Medical School
name: Ilker Ital, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
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.