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

Not Applicable

Completed

• Conditions: Arterial Line
• Interventions: Device: Smart glasses; Device: Control

• Registration Number: NCT04329026
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-03-29
• Study First Submitted QC: 2020-03-30
• Study First Posted: 2020-04-01
• Study Start: 2020-04-07
• Primary Completion: 2020-12-01
• Study Completion: 2020-12-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-17
• Last Update Posted: 2021-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 116

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart Glasses	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	Control	The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.

Primary Outcome Measures

Name	Time	Method
First attempt success rate	During radial artery cannulation (up to 1 hour)	Success at the first skin puncture

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jin-Tae Kim; 🇰🇷 Seoul, Korea, Republic of