UltrasonographyNCT03565419
Use of Smart Glasses for Ultrasound Guided Peripheral Venous Access
A study testing Smart glasses in people with Ultrasonography and Catheterization, run by Inje University at 1 site in South Korea.
Trial summary
Investigators aimed to explore the feasibility of smart glasses connected to a wireless ultrasound transducer for the peripheral venous access. Residents who have basic skills of ultrasound guided procedure participate in the simulation. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ultrasonography, Catheterization
- What is being tested?
- Smart glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jun 2018to 21 Jul 2018
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Doctors who have basic skill for the ultrasound guided procedures and agree to participate the simulation
Who cannot join
- Doctors who do not agree to participate the simulation
- Doctors who do not have basic skill for the ultrasound guided procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of Smart Glasses During Ultrasound Guided Peripheral Venous Access: a Randomized Controlled Crossover Pilot Study
Investigators aimed to explore the feasibility of smart glasses connected to a wireless ultrasound transducer for the peripheral venous access. Residents who have basic skills of ultrasound guided procedure participate in the simulation. Each participant plays the following two roles for ultrasound guided peripheral venous access; ultrasound guided peripheral venous access with and without wearing smart glasses. The order of performing two roles is determined by a randomized process and the gap between two roles are five days. The primary outcome is the time of successful blood aspiration, and secondary outcomes are first time success rate, the number of skin puncture, the number of needle redirection, the number of head movement, and subjective difficulty.
- Conditions
- Ultrasonography, Catheterization
- Being tested
- Smart glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart glassesDevice
Participants confirm the real-time ultrasound image displayed on the viewer of smart glasses.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Participants conduct the ultrasound-guided peripheral cannulation while they confirm real-time images displayed on the viewer next to the phantom. |
| Intervention | Experimental | Participants conduct the ultrasound-guided peripheral cannulation wearing smart glasses. They confirm real-time images displayed on the viewer of smart glasses. Receives: Device: Smart glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
time for successful blood aspiration
duration from application of probe to successful aspiration
Measured: up to 1 month
Secondary outcomes (5)
first time success rate
chance for successful aspiration within 90 seconds
Measured: up to 1 month
number of skin puncture
number of skin puncture during ultrasound guided venous access
Measured: up to 1 month
number of needle redirection
number of needle redirection during ultrasound guided venous access
Measured: up to 1 month
number of head movement
number of participant's head movement during ultrasound guided venous access
Measured: up to 1 month
subjective difficulty of procedure
measuring subjective difficulty with the 100mm VAS (0: easy, 100: difficult)
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2018
- Study start20 Jun 2018
- Primary completion19 Jul 2018
- Study completion21 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies of the same condition, open and under way.
- 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Foundation of Korea
- Responsible party
- Principal investigator, Joon Min Park, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03565419
- Sponsor's protocol ID
- 2018-04-013
- Status last verified
- Jul 2018
- First submitted
- 4 May 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of Smart Glasses During Ultrasound Guided Peripheral Venous Access: a Randomized Controlled Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT03565419
- Acronym / sponsor ID
- 2018-04-013
- Conditions
- Ultrasonography, Catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Collaborators
- National Research Foundation of Korea
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 21 Jul 2018 (actual)
- First posted
- 21 Jun 2018 (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.
Investigators aimed to explore the feasibility of smart glasses connected to a wireless ultrasound transducer for the peripheral venous access. Residents who have basic skills of ultrasound guided procedure participate in the simulation. Each participant plays the following two roles for ultrasound guided peripheral venous access; ultrasound guided peripheral venous access with and without wearing smart glasses. The order of performing two roles is determined by a randomized process and the gap between two roles are five days. The primary outcome is the time of successful blood aspiration, and secondary outcomes are first time success rate, the number of skin puncture, the number of needle redirection, the number of head movement, and subjective difficulty.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Participants conduct the ultrasound-guided peripheral cannulation while they confirm real-time images displayed on the viewer next to the phantom. |
| Intervention | Experimental | Device: Smart glassesParticipants conduct the ultrasound-guided peripheral cannulation wearing smart glasses. They confirm real-time images displayed on the viewer of smart glasses. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Doctors who have basic skill for the ultrasound guided procedures and agree to participate the simulation
Key exclusion criteria (2 listed)
- Doctors who do not agree to participate the simulation
- Doctors who do not have basic skill for the ultrasound guided procedures
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 |
|---|---|---|
| Smart glassesParticipants confirm the real-time ultrasound image displayed on the viewer of smart glasses. | Device | Intervention |
Primary outcome
time for successful blood aspiration
Time frame: up to 1 month
duration from application of probe to successful aspiration
5 secondary outcomes
first time success rate
Time frame: up to 1 month
number of skin puncture
Time frame: up to 1 month
number of needle redirection
Time frame: up to 1 month
number of head movement
Time frame: up to 1 month
subjective difficulty of procedure
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smart glasses in people with Ultrasonography and Catheterization, run by Inje University at 1 site in South Korea.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jul 2018. 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time for successful blood aspiration (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jul 2018.