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Arterial LineNCT04329026

Smart-glasses During the US-guided Radial Arterial Catheterization in Pediatric Patients: a RCT

A study testing Smart glasses in people with Arterial Line, run by Seoul National University Hospital at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The primary objective of the study is to evaluate the effect of smart glasses (Head-mounted display Moverio BT-300 (Epson Inc., USA)) on the first-attempt success rate of radial artery cannulation in pediatric patients. Read more about this study

Who is it for?
Ages Up to 2 years
Conditions the study is for
Arterial Line
What is being tested?
Smart glasses
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
116 participants
Where
1 siteSouth Korea
Study dates
7 Apr 2020to 1 Dec 2020
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 Up to 2 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • General anesthesia
  • Arterial cannulation for hemodynamic monitoring, multiple blood sample

Who cannot join

  • Unstable vital sign, significant arrhythmia or hypotension, Shock
  • High risk of peripheral ischemia
  • Skin disease, infection, hematoma, recent cannulation at radial artery

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Jin-Tae Kim

    Seoul

Other trials in South Korea

About this study

Official title: The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial

The primary objective of the study is to evaluate the effect of smart glasses (Head-mounted display Moverio BT-300 (Epson Inc., USA)) on the first-attempt success rate of radial artery cannulation in pediatric patients. This study hypothesizes that the use of smart glasses improves the hand-eye coordination and the first-attempt success rate of radial artery cannulation. This is a single-center, randomized, placebo-controlled study comparing the real-time ultrasound image through smart glasses (intervention group) or the ultrasound machine's monitor (control group) during the radial arterial cannulation in pediatric patients undergoing general anesthesia.

Conditions
Arterial Line
Being tested
Smart glasses, Control
Keywords
Radial Artery, Vascular Catheters, Smart Glassess

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Smart glassesDevice

    The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.

  • ControlDevice

    The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.

Study groups in NCT04329026
Study groupRoleWhat they receive
Smart GlassesExperimentalThe real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
Receives: Device: Smart glasses
ControlPlacebo comparatorThe real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.
Receives: Device: Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First attempt success rate

    Success at the first skin puncture

    Measured: During radial artery cannulation (up to 1 hour)

Secondary outcomes (8)

  1. Size of radial artery

    Internal diameter of radial artery

    Measured: Before and after subcutaneous injection of drugs (up to 1 hour)

  2. depth of radial artery

    depth of radial artery from the skin

    Measured: During radial artery cannulation (up to 1 hour)

  3. Overall attempt

    Number of attempt of radial artery cannulation

    Measured: During radial artery cannulation (up to 1 hour)

  4. Overall Procedure time

    From needle puncture, to Arterial waveform

    Measured: During radial artery cannulation (up to 1 hour)

  5. Overall success rate

    Success within 2 skin puncture and within 10 minutes at the chosen radial artery

    Measured: During radial artery cannulation (up to 1 hour)

  6. Malfunction of radial artery catheter

    Malfunction of Invasive blood pressure monitoring, Sampling

    Measured: After radial artery cannulation assessed during anesthesia (up to 24 hour)

  7. Complication rate

    Hematoma, Distal ischemia, Spasm accessed by ultrasound

    Measured: After radial artery cannulation assessed up to PACU, PICU stay (up to 24 hour)

  8. Operator's satisfaction

    Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)

    Measured: During radial artery cannulation (up to 1 hour)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2020
  2. Study start7 Apr 2020
  3. Primary completion1 Dec 2020
  4. Study completion1 Dec 2020

Resources

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
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04329026
Sponsor's protocol ID
Smart Glass A-line
Status last verified
Feb 2021
First submitted
29 Mar 2020
Last updated
18 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • White L, Halpin A, Turner M, Wallace L. Ultrasound-guided radial artery cannulation in adult and paediatric populations: a systematic review and meta-analysis. Br J Anaesth. 2016 May;116(5):610-7. doi: 10.1093/bja/aew097.

    PubMed 27106964

  • Kim EH, Lee JH, Song IK, Kim JT, Lee WJ, Kim HS. Posterior Tibial Artery as an Alternative to the Radial Artery for Arterial Cannulation Site in Small Children: A Randomized Controlled Study. Anesthesiology. 2017 Sep;127(3):423-431. doi: 10.1097/ALN.0000000000001774.

    PubMed 28682811

  • Cuper NJ, de Graaff JC, Hartman BJ, Verdaasdonk RM, Kalkman CJ. Difficult arterial cannulation in children: is a near-infrared vascular imaging system the answer? Br J Anaesth. 2012 Sep;109(3):420-6. doi: 10.1093/bja/aes193. Epub 2012 Jun 26.

    PubMed 22735300

  • Ishii S, Shime N, Shibasaki M, Sawa T. Ultrasound-guided radial artery catheterization in infants and small children. Pediatr Crit Care Med. 2013 Jun;14(5):471-3. doi: 10.1097/PCC.0b013e31828a8657.

    PubMed 23628835

  • Song IK, Choi JY, Lee JH, Kim EH, Kim HJ, Kim HS, Kim JT. Short-axis/out-of-plane or long-axis/in-plane ultrasound-guided arterial cannulation in children: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):522-7. doi: 10.1097/EJA.0000000000000453.

    PubMed 26986774

  • Maruyama K, Watanabe E, Kin T, Saito K, Kumakiri A, Noguchi A, Nagane M, Shiokawa Y. Smart Glasses for Neurosurgical Navigation by Augmented Reality. Oper Neurosurg. 2018 Nov 1;15(5):551-556. doi: 10.1093/ons/opx279.

    PubMed 29373710

Questions about this trial

What is this clinical trial studying?

A study testing Smart glasses in people with Arterial Line, run by Seoul National University Hospital 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 2 inclusion and 3 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 18 Feb 2021. 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. Some participants in this study may receive a placebo. 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?

First attempt success rate (time frame: During radial artery cannulation (up to 1 hour)). 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 NCT04329026, which also lists 6 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 18 Feb 2021.

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