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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05030649
Other study ID # Smart Glass A-line Less Exp
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 17, 2021
Est. completion date February 7, 2023

Study information

Verified date March 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
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 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.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date February 7, 2023
Est. primary completion date February 7, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 7 Years
Eligibility Inclusion Criteria: - General anesthesia - Arterial cannulation for hemodynamic monitoring, multiple blood sample Exclusion Criteria: - Unstable vital signs, significant arrhythmia or hypotension, Shock - High risk of peripheral ischemia - Skin disease, infection, hematoma, recent cannulation at theradial artery

Study Design


Related Conditions & MeSH terms


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 (8)

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. — View 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. — 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

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. — 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. — 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 During radial artery cannulation (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 Ultrasound image time From ultrasound probe application, to get radial artery image on the ultrasound screen During radial artery cannulation (up to 1 hour)
Secondary Arterial cannulation time From needle puncture, to Arterial waveform During radial artery cannulation (up to 1 hour)
Secondary Overall Procedure time From ultrasound probe application, 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 experience The prior experience of the operator's in ultrasound-guided vascular cannulation (5-10 cannulations, 10-30 cannulations, 30-50 cannulations, 50-100 cannulations) During radial artery cannulation (up to 1 hour)
Secondary Operator's satisfaction Operator's satisfaction, 5 scale (Worst, Poor, Acceptable, Good, Best) During radial artery cannulation (up to 1 hour)
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