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

Study Overview
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Brief Summary
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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.

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

Conditions
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Arterial Line

Intervention / Treatment
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* Device: Smart glasses
* Device: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart Glasses<br>The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation. | Device: Smart glasses<br>* The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.<br>|
| Placebo Comparator: Control<br>The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation. | Device: Control<br>* The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First attempt success rate | Success at the first skin puncture | During radial artery cannulation (up to 1 hour) | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Radial Artery, Vascular Catheters, Smart Glassess