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

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.

Study Overview

• Status: Completed
• Conditions: Arterial Line
• Intervention / Treatment: Device: Smart glasses; Device: Control

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Jin-Tae Kim

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Smart Glasses; 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; The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
Placebo Comparator: Control; The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.	Device: Control; The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt success rate	Success at the first skin puncture	During radial artery cannulation (up to 1 hour)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Size of radial artery	Internal diameter of radial artery	Before and after subcutaneous injection of drugs (up to 1 hour)
depth of radial artery	depth of radial artery from the skin	During radial artery cannulation (up to 1 hour)
Overall attempt	Number of attempt of radial artery cannulation	During radial artery cannulation (up to 1 hour)
Overall Procedure time	From needle puncture, to Arterial waveform	During radial artery cannulation (up to 1 hour)
Overall success rate	Success within 2 skin puncture and within 10 minutes at the chosen radial artery	During radial artery cannulation (up to 1 hour)
Malfunction of radial artery catheter	Malfunction of Invasive blood pressure monitoring, Sampling	After radial artery cannulation assessed during anesthesia (up to 24 hour)
Complication rate	Hematoma, Distal ischemia, Spasm accessed by ultrasound	After radial artery cannulation assessed up to PACU, PICU stay (up to 24 hour)
Operator's satisfaction	Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best)	During radial artery cannulation (up to 1 hour)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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 (Hagerstown). 2018 Nov 1;15(5):551-556. doi: 10.1093/ons/opx279.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2020
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: March 29, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 17, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Radial Artery; Vascular Catheters; Smart Glassess
• Other Study ID Numbers: Smart Glass A-line

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No