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

NCT05030649 | Completed

• 1 other identifier: Smart Glass A-line Less Exp
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Arterial Line

Keywords

Radial Artery; Vascular Catheters; Smart Glassess; Less experienced

Outcome Measures

Primary Outcomes (1)

• First attempt success rate

  Success at the first skin puncture

  During radial artery cannulation (up to 1 hour)

Secondary Outcomes (11)

• Size of radial artery

  During radial artery cannulation (up to 1 hour)

• depth of radial artery

  During radial artery cannulation (up to 1 hour)

• Overall attempt

  During radial artery cannulation (up to 1 hour)

• Ultrasound image time

  During radial artery cannulation (up to 1 hour)

• Arterial cannulation time

  During radial artery cannulation (up to 1 hour)

Study Arms (2)

Smart Glasses

EXPERIMENTAL

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

Device: Smart glasses

Control

ACTIVE COMPARATOR

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

Device: Control

Interventions

Smart glasses DEVICE

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

Smart Glasses

Control DEVICE

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

Control

Eligibility Criteria

• Age: Up to 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (9)

• 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.

  PMID: 27106964 BACKGROUND

• 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.

  PMID: 28682811 BACKGROUND

• 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.

  PMID: 22735300 BACKGROUND

• 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.

  PMID: 23628835 BACKGROUND

• 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.

  PMID: 26986774 BACKGROUND

• 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.

  PMID: 29373710 BACKGROUND

• 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.

  PMID: 23151422 BACKGROUND

• 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.

  PMID: 28688136 BACKGROUND

• 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.

  PMID: 38517311 DERIVED

MeSH Terms

Interventions

Smart Glasses

Intervention Hierarchy (Ancestors)

Wearable Electronic Devices; Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Jin-Tae Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 1, 2021
• Study Start: September 17, 2021
• Primary Completion: February 7, 2023
• Study Completion: February 7, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

KR (1)