Nerve BlockNCT05409807
Comparison of Classical Ultrasound Screen and Combined Wearable Display in Interscalene Nerve Blocks
A study testing Ultrasound guided smart glasses assisted and Ultrasound guided in people with Nerve Block, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Block
- What is being tested?
- Ultrasound guided smart glasses assisted and Ultrasound guided
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2023to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are planned to undergo surgery under general anesthesia
- Patients scheduled for postoperative analgesia after shoulder surgery
Who cannot join
- Local anesthetic allergy
- Skin disease, infection, hematoma
- Chronic obstructive pulmonary disease
- Hepatic, renal, cardiac failures
- Pregnancy
- Uncooperative patient
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bolu Abant İzzet Baysal University Faculty of Medicine
Bolu, 14030
Kasım İlker İtal, MD, +905337723300, ilkerital@gmail.com
Tacettin Ayanoglu, MD, +905312331970 ext. İtal, ilkerital@gmail.com
About this study
Official title: Comparison of Classical Ultrasound Guided Method and Combined Wearable Display Technology Method With Ultrasound in Interscalene Nerve Block Applied in Shoulder Surgery
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.
Read the 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
- Being tested
- Ultrasound guided smart glasses assisted, Ultrasound guided
- Keywords
- Interscalene Block, Smart Glasses, Wearable Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided smart glasses assistedDevice
Ultrasound guided smart glasses assisted interscalene nerve block
Ultrasound guidedDevice
Ultrasound guided interscalene nerve block
| Study group | Role | What they receive |
|---|---|---|
| Classic Ultrasound Guided | Experimental | Ultrasound guided interscalene nerve block Receives: Device: Ultrasound guided |
| Smart Glasses Assisted | Experimental | Ultrasound guided smart glasses assisted interscalene nerve block Receives: Device: Ultrasound guided smart glasses assisted |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
Ultrasound visualization and neurostimulator confirmation of the nerve plexus sheath being reached
Measured: During peripheral nerve block procedure. Not to exceed 20 minutes
Secondary outcomes (6)
Overall attempt
Number of attempt of needling
Measured: During peripheral nerve block procedure. Not to exceed 20 minutes
Ultrasound image time
From ultrasound probe application, to get nerves image on the ultrasound screen
Measured: During peripheral nerve block procedure. Not to exceed 20 minutes
Nerve block time
From needle puncture, to local anesthetic spreading
Measured: During peripheral nerve block procedure. Not to exceed 20 minutes
Overall success rate
The sensory and motor effect of the block
Measured: During peripheral nerve block procedure. Up to 1 day
Operator's satisfaction
Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)
Measured: During peripheral nerve block procedure. Not to exceed 20 minutes
Complication rate
Block failure, pneumothorax, hematoma, local anesthetic toxicity
Measured: Through study completion, an average of 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start30 Jan 2023
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nerve BlockStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ilker Ital, Abant Izzet Baysal University
- Investigators
- Ilker Ital, MD, Principal investigator, Bolu Abant İzzet Baysal Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409807
- Sponsor's protocol ID
- AIBU-TF-AR-II-002
- Status last verified
- May 2023
- First submitted
- 8 May 2022
- Last updated
- 6 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29927851Przkora 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.
PubMed 33400431Lim 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.
PubMed 31910508Jang 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.
PubMed 34352073Kasuya 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.
PubMed 28477229
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Classical Ultrasound Guided Method and Combined Wearable Display Technology Method With Ultrasound in Interscalene Nerve Block Applied in Shoulder Surgery
- ClinicalTrials.gov ID
- NCT05409807
- Acronym / sponsor ID
- AIBU-TF-AR-II-002
- Conditions
- Nerve Block
- Keywords
- Interscalene Block, Smart Glasses, Wearable Technology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Classic Ultrasound Guided | Experimental | Device: Ultrasound guidedUltrasound guided interscalene nerve block |
| Smart Glasses Assisted | Experimental | Device: Ultrasound guided smart glasses assistedUltrasound guided smart glasses assisted interscalene nerve block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are planned to undergo surgery under general anesthesia
- Patients scheduled for postoperative analgesia after shoulder surgery
Key exclusion criteria (6 listed)
- Local anesthetic allergy
- Skin disease, infection, hematoma
- Chronic obstructive pulmonary disease
- Hepatic, renal, cardiac failures
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided smart glasses assistedUltrasound guided smart glasses assisted interscalene nerve block | Device | Smart Glasses Assisted |
| Ultrasound guidedUltrasound guided interscalene nerve block | Device | Classic Ultrasound Guided |
Primary outcome
First attempt success rate
Time frame: During peripheral nerve block procedure. Not to exceed 20 minutes
Ultrasound visualization and neurostimulator confirmation of the nerve plexus sheath being reached
6 secondary outcomes
Overall attempt
Time frame: During peripheral nerve block procedure. Not to exceed 20 minutes
Ultrasound image time
Time frame: During peripheral nerve block procedure. Not to exceed 20 minutes
Nerve block time
Time frame: During peripheral nerve block procedure. Not to exceed 20 minutes
Overall success rate
Time frame: During peripheral nerve block procedure. Up to 1 day
Operator's satisfaction
Time frame: During peripheral nerve block procedure. Not to exceed 20 minutes
Complication rate
Time frame: Through study completion, an average of 2 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Background: PubMed 29927851Yoon 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.
- Background: PubMed 33400431Przkora 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.
- Background: PubMed 31910508Lim 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.
- Background: PubMed 34352073Jang 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.
- Background: PubMed 28477229Kasuya 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilker Ital, MD principal investigator
Bolu Abant İzzet Baysal Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided smart glasses assisted and Ultrasound guided in people with Nerve Block, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilker Ital, MD ((0374) 253 46 56, ilkerital@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First attempt success rate (time frame: During peripheral nerve block procedure. Not to exceed 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05409807, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.