Clinical trial NCT04329026: Smart-glasses During the US-guided Radial Arterial Catheterization in Pediatric Patients: a RCT
Official title: The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Line
Keywords: Radial Artery
Vascular Catheters
Smart Glassess
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-04-01
Enrollment: 116
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: First attempt success rate
timeFrame: During radial artery cannulation (up to 1 hour)
Secondary outcomes:
measure: Size of radial artery
timeFrame: Before and after subcutaneous injection of drugs (up to 1 hour)
measure: depth of radial artery
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Overall attempt
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Overall Procedure time
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Overall success rate
timeFrame: During radial artery cannulation (up to 1 hour)
measure: Malfunction of radial artery catheter
timeFrame: After radial artery cannulation assessed during anesthesia (up to 24 hour)
measure: Complication rate
timeFrame: After radial artery cannulation assessed up to PACU, PICU stay (up to 24 hour)
measure: Operator's satisfaction
timeFrame: During radial artery cannulation (up to 1 hour)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin-Tae Kim
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.