Comparison of Classical Ultrasound Screen and Combined Wearable Display in Interscalene Nerve Blocks
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Classic Ultrasound Guided Ultrasound guided interscalene nerve block |
Device: Ultrasound guided
Ultrasound guided interscalene nerve block
|
| Experimental: Smart Glasses Assisted Ultrasound guided smart glasses assisted interscalene nerve block |
Device: Ultrasound guided smart glasses assisted
Ultrasound guided smart glasses assisted interscalene nerve block
|
Outcome Measures
Primary Outcome Measures
- First attempt success rate [During peripheral nerve block procedure. Not to exceed 20 minutes]
Ultrasound visualization and neurostimulator confirmation of the nerve plexus sheath being reached
Secondary Outcome Measures
- Overall attempt [During peripheral nerve block procedure. Not to exceed 20 minutes]
Number of attempt of needling
- Ultrasound image time [During peripheral nerve block procedure. Not to exceed 20 minutes]
From ultrasound probe application, to get nerves image on the ultrasound screen
- Nerve block time [During peripheral nerve block procedure. Not to exceed 20 minutes]
From needle puncture, to local anesthetic spreading
- Overall success rate [During peripheral nerve block procedure. Up to 1 day]
The sensory and motor effect of the block
- Operator's satisfaction [During peripheral nerve block procedure. Not to exceed 20 minutes]
Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)
- Complication rate [Through study completion, an average of 2 week]
Block failure, pneumothorax, hematoma, local anesthetic toxicity
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients who are planned to undergo surgery under general anesthesia
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Patients scheduled for postoperative analgesia after shoulder surgery
Exclusion Criteria:
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Local anesthetic allergy
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Skin disease, infection, hematoma
-
Chronic obstructive pulmonary disease
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Hepatic, renal, cardiac failures
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Pregnancy
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Uncooperative patient
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Abant Izzet Baysal University
Investigators
- Principal Investigator: Ilker Ital, MD, Bolu Abant İzzet Baysal Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- AIBU-TF-AR-II-002