AR for Pediatric Central Venous Catheterization

NCT ID: NCT04378166

Last Updated: 2022-05-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-12

Study Completion Date

2023-04-30

Brief Summary

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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.

Detailed Description

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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

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compares central venous catheterization using smart-glasses and conventional method
Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Smart glasses

Application of smart glasses for ultrasound-guided central venous catheterization

Group Type EXPERIMENTAL

Smart glass

Intervention Type DEVICE

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

Control

Conventional ultrasound-guided central venous catheterization

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Smart glass

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin-Tae Kim

MD, PhD, Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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

Role: CONTACT

82-2-2072-3661

Facility Contacts

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Jin-Tae Kim, Pf.

Role: primary

+82-2-2072-3295

References

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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.

Reference Type BACKGROUND
PMID: 8435256 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27057741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11012954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30361397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28068887 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29785148 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27930431 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30442261 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23478546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26248059 (View on PubMed)

Other Identifiers

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2003-018-1106

Identifier Type: -

Identifier Source: org_study_id

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