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AnesthesiaNCT04378166

AR for Pediatric Central Venous Catheterization

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

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is intended to investigate usefulness of smart-glasses for ultrasound-guided central venous catheterization in pediatric patients, by comparing success rate and elapsed time. The hypothesis is that smart-glasses would increase success rate in first trial. Read more about this study

Who is it for?
Ages Up to 6 years
Conditions the study is for
Anesthesia
What is being tested?
Smart glass
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteSouth Korea
Study dates
12 May 2020to 30 Apr 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 Up to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Patients who are planned to undergo surgery under general anesthesia
  • Patients in need for central venous catheterization during anesthesia

Who cannot join

  • Patients who have any of infection, hematoma, skin lesion, recent attempt of puncture at right internal jugular vein
  • Patients with unstable vital sign prior to anesthetic induction
  • Patients who are not eligible for catheterization at right internal jugular vein
  • Refusal of legal guardian of patient

Trial locations and contacts

1 site in 1 country.

Sang-Hwan Ji, M.D., M.S. contact

82-2-2072-3661

taepoongshin@gmail.com

South Korea1 site, 1 recruiting

  • Seoul National University Hospital

    Seoul, 110-744

    Jin-Tae Kim, Pf., +82-2-2072-3295, jintae73@gmail.com

    Recruiting

Other trials in South Korea

About this study

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

This study is intended to investigate usefulness of smart-glasses for ultrasound-guided central venous catheterization in pediatric patients, by comparing success rate and elapsed time. The hypothesis is that smart-glasses would increase success rate in first trial.

Read the detailed description

After obtaining informed consent from patients' legal guardian, children aged 6 or less undergoing surgery with need for central venous catheterization will be enrolled to the study.

Patients will be divided into either study group or control group. After anesthetic induction, central venous catheterization will be performed under ultrasound guidance. For patients in study group, the practitioner will be equipped with smart-glasses, while conventional ultrasound-guided catheterization will be performed for patients in control group.

Success rate of first trial, overall success rate, elapsed time during catheterization, complication regarding catheterization will be recorded and compared.

Conditions
Anesthesia
Being tested
Smart glass

What participants receive

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

  • Smart glassDevice

    Practitioner wears smart glasses connected to ultrasound machine during central venous catheterization

Study groups in NCT04378166
Study groupRoleWhat they receive
Smart glassesExperimentalApplication of smart glasses for ultrasound-guided central venous catheterization
Receives: Device: Smart glass
ControlNo interventionConventional ultrasound-guided central venous catheterization

What is being measured

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

  1. 1st success rate

    Success rate of central venous catheterization in first trial

    Measured: From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 20 minutes.

Secondary outcomes (4)

  1. Overall success rate

    Overall success rate of central venous catheterization

    Measured: From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 3 attempts and 20 minutes.

  2. Elapsed time for catheterization

    Overall elapsed time of central venous catheterization

    Measured: From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes.

  3. Complication

    Incidence and characteristics of complication related to central venous catheterization

    Measured: From end of catheterization to 24 hours after catheterization

  4. Satisfaction score

    5-points satisfaction score of practitioner (5 - Best / 4 - Good / 3 - Acceptable / 2 - Poor / 1 - Worst)

    Measured: From start of catheterization to end of catheterization. Not to exceed 20 minutes.

Timeline

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

  1. First posted7 May 2020
  2. Study start12 May 2020
  3. Primary completion28 Feb 2023 (estimated)
  4. Study completion30 Apr 2023 (estimated)

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Compares central venous catheterization using smart-glasses and conventional method
Masking
Single blind
Who is masked
Participant
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04378166
Sponsor's protocol ID
2003-018-1106
Status last verified
May 2022
First submitted
4 May 2020
Last updated
5 May 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alderson PJ, Burrows FA, Stemp LI, Holtby HM. Use of ultrasound to evaluate internal jugular vein anatomy and to facilitate central venous cannulation in paediatric patients. Br J Anaesth. 1993 Feb;70(2):145-8. doi: 10.1093/bja/70.2.145.

    PubMed 8435256

  • Lau CS, Chamberlain RS. Ultrasound-guided central venous catheter placement increases success rates in pediatric patients: a meta-analysis. Pediatr Res. 2016 Aug;80(2):178-84. doi: 10.1038/pr.2016.74. Epub 2016 Apr 8.

    PubMed 27057741

  • Verghese ST, McGill WA, Patel RI, Sell JE, Midgley FM, Ruttimann UE. Comparison of three techniques for internal jugular vein cannulation in infants. Paediatr Anaesth. 2000;10(5):505-11. doi: 10.1046/j.1460-9592.2000.00554.x.

    PubMed 11012954

  • de Souza TH, Brandao MB, Nadal JAH, Nogueira RJN. Ultrasound Guidance for Pediatric Central Venous Catheterization: A Meta-analysis. Pediatrics. 2018 Nov;142(5):e20181719. doi: 10.1542/peds.2018-1719.

    PubMed 30361397

  • Hiranaka T, Nakanishi Y, Fujishiro T, Hida Y, Tsubosaka M, Shibata Y, Okimura K, Uemoto H. The Use of Smart Glasses for Surgical Video Streaming. Surg Innov. 2017 Apr;24(2):151-154. doi: 10.1177/1553350616685431. Epub 2017 Jan 9.

    PubMed 28068887

  • Huang CY, Thomas JB, Alismail A, Cohen A, Almutairi W, Daher NS, Terry MH, Tan LD. The use of augmented reality glasses in central line simulation: "see one, simulate many, do one competently, and teach everyone". Adv Med Educ Pract. 2018 May 10;9:357-363. doi: 10.2147/AMEP.S160704. eCollection 2018.

    PubMed 29785148

  • Rochlen LR, Levine R, Tait AR. First-Person Point-of-View-Augmented Reality for Central Line Insertion Training: A Usability and Feasibility Study. Simul Healthc. 2017 Feb;12(1):57-62. doi: 10.1097/SIH.0000000000000185.

    PubMed 27930431

  • Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.

    PubMed 30442261

  • Bruzoni M, Slater BJ, Wall J, St Peter SD, Dutta S. A prospective randomized trial of ultrasound- vs landmark-guided central venous access in the pediatric population. J Am Coll Surg. 2013 May;216(5):939-43. doi: 10.1016/j.jamcollsurg.2013.01.054. Epub 2013 Mar 7.

    PubMed 23478546

  • Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6.

    PubMed 26248059

Questions about this trial

What is this clinical trial studying?

A study testing Smart glass in people with Anesthesia, 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 4 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 5 May 2022. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sang-Hwan Ji, M.D., M.S. (82-2-2072-3661, taepoongshin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

1st success rate (time frame: From start of central venous catheterization to successful placement of the guidewire at superior vena cava. 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 NCT04378166, which also lists 10 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 5 May 2022.

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