Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Trainees

NCT ID: NCT05030649

Last Updated: 2023-03-07

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

COMPLETED

Clinical Phase

NA

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-17

Study Completion Date

2023-02-07

Brief Summary

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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 by less experienced trainees. 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 by less experienced trainees.

Detailed Description

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Conditions

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Arterial Line

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Smart Glasses

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

Group Type EXPERIMENTAL

Smart glasses

Intervention Type DEVICE

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

Control

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

Group Type ACTIVE_COMPARATOR

Control

Intervention Type DEVICE

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

Interventions

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Smart glasses

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

Intervention Type DEVICE

Control

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Unstable vital signs, significant arrhythmia or hypotension, Shock
* High risk of peripheral ischemia
* Skin disease, infection, hematoma, recent cannulation at theradial artery
Maximum Eligible Age

7 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

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin-Tae Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Jin-Tae Kim

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 27106964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28682811 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22735300 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23628835 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26986774 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29373710 (View on PubMed)

Ueda K, Puangsuvan S, Hove MA, Bayman EO. Ultrasound visual image-guided vs Doppler auditory-assisted radial artery cannulation in infants and small children by non-expert anaesthesiologists: a randomized prospective study. Br J Anaesth. 2013 Feb;110(2):281-6. doi: 10.1093/bja/aes383. Epub 2012 Nov 14.

Reference Type BACKGROUND
PMID: 23151422 (View on PubMed)

Anantasit N, Cheeptinnakorntaworn P, Khositseth A, Lertbunrian R, Chantra M. Ultrasound Versus Traditional Palpation to Guide Radial Artery Cannulation in Critically Ill Children: A Randomized Trial. J Ultrasound Med. 2017 Dec;36(12):2495-2501. doi: 10.1002/jum.14291. Epub 2017 Jul 8.

Reference Type BACKGROUND
PMID: 28688136 (View on PubMed)

Kim JT, Park JB, Kang P, Ji SH, Kim EH, Lee JH, Kim HS, Jang YE. Effectiveness of head-mounted ultrasound display for radial arterial catheterisation in paediatric patients by anaesthesiology trainees: A randomised clinical trial. Eur J Anaesthesiol. 2024 Jul 1;41(7):522-529. doi: 10.1097/EJA.0000000000001985. Epub 2024 Mar 21.

Reference Type DERIVED
PMID: 38517311 (View on PubMed)

Other Identifiers

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Smart Glass A-line Less Exp

Identifier Type: -

Identifier Source: org_study_id

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