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
1 other identifier
interventional
116
1 country
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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedStudy Start
First participant enrolled
April 7, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 18, 2021
February 1, 2021
8 months
March 29, 2020
February 17, 2021
Conditions
Keywords
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 (8)
Size of radial artery
Before and after subcutaneous injection of drugs (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)
Overall Procedure time
During radial artery cannulation (up to 1 hour)
Overall success rate
During radial artery cannulation (up to 1 hour)
- +3 more secondary outcomes
Study Arms (2)
Smart Glasses
EXPERIMENTALThe real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
Control
PLACEBO COMPARATORThe real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.
Interventions
The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.
Eligibility Criteria
You may qualify if:
- General anesthesia
- Arterial cannulation for hemodynamic monitoring, multiple blood sample
You may not qualify if:
- Unstable vital sign, significant arrhythmia or hypotension, Shock
- High risk of peripheral ischemia
- Skin disease, infection, hematoma, recent cannulation at radial artery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jin-Tae Kim
Seoul, South Korea
Related Publications (6)
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: 27106964BACKGROUNDKim 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: 28682811BACKGROUNDCuper 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: 22735300BACKGROUNDIshii 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: 23628835BACKGROUNDSong 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: 26986774BACKGROUNDMaruyama 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: 29373710BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jin-Tae Kim, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 29, 2020
First Posted
April 1, 2020
Study Start
April 7, 2020
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
February 18, 2021
Record last verified: 2021-02