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

Arterial Line Clinical Trial

Official title:

The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04329026
• Other study ID #: Smart Glass A-line
• Status: Completed
• Phase: N/A
• Start date: April 7, 2020
• Est. completion date: December 1, 2020

Study information

• Verified date: February 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Line

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jin-Tae Kim	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

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