Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Trainees

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 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.

Official Title
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The Usefulness of Smart-glasses During the Ultrasound-guided Radial Arterial Catheterization in Pediatric Patients by Less Experienced Trainees: 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 signs, significant arrhythmia or hypotension, Shock High risk of peripheral ischemia Skin disease, infection, hematoma, recent cannulation at theradial artery

Ages Eligible for Study
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Maximum Age: 7 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: Single


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>|
| Active 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 | During radial artery cannulation (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) | 
| Ultrasound image time | From ultrasound probe application, to get radial artery image on the ultrasound screen | During radial artery cannulation (up to 1 hour) | 
| Arterial cannulation time | From needle puncture, to Arterial waveform | During radial artery cannulation (up to 1 hour) | 
| Overall Procedure time | From ultrasound probe application, 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 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) | 
| 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, Less experienced