AR for Pediatric Central Venous Catheterization

Study Overview
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Brief Summary
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This study is intended to investigate usefulness of smart-glasses for ultrasound-guided central venous catheterization in pediatric patients, by comparing success rate and elapsed time. The hypothesis is that smart-glasses would increase success rate in first trial.

Detailed Description
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After obtaining informed consent from patients' legal guardian, children aged 6 or less undergoing surgery with need for central venous catheterization will be enrolled to the study. Patients will be divided into either study group or control group. After anesthetic induction, central venous catheterization will be performed under ultrasound guidance. For patients in study group, the practitioner will be equipped with smart-glasses, while conventional ultrasound-guided catheterization will be performed for patients in control group. Success rate of first trial, overall success rate, elapsed time during catheterization, complication regarding catheterization will be recorded and compared.

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

Conditions
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Anesthesia

Intervention / Treatment
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* Device: Smart glass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are planned to undergo surgery under general anesthesia Patients in need for central venous catheterization during anesthesia Exclusion Criteria: Patients who have any of infection, hematoma, skin lesion, recent attempt of puncture at right internal jugular vein Patients with unstable vital sign prior to anesthetic induction Patients who are not eligible for catheterization at right internal jugular vein Refusal of legal guardian of patient

Ages Eligible for Study
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Maximum Age: 6 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Compares central venous catheterization using smart-glasses and conventional method
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smart glasses<br>Application of smart glasses for ultrasound-guided central venous catheterization | Device: Smart glass<br>* Practitioner wears smart glasses connected to ultrasound machine during central venous catheterization<br>|
| No Intervention: Control<br>Conventional ultrasound-guided central venous catheterization | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1st success rate | Success rate of central venous catheterization in first trial | From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 20 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall success rate | Overall success rate of central venous catheterization | From start of central venous catheterization to successful placement of the guidewire at superior vena cava. Not to exceed 3 attempts and 20 minutes. | 
| Elapsed time for catheterization | Overall elapsed time of central venous catheterization | From start of central venous catheterization to finish of catheterization. Not to exceed 3 attempts and 20 minutes. | 
| Complication | Incidence and characteristics of complication related to central venous catheterization | From end of catheterization to 24 hours after catheterization | 
| Satisfaction score | 5-points satisfaction score of practitioner (5 - Best / 4 - Good / 3 - Acceptable / 2 - Poor / 1 - Worst) | From start of catheterization to end of catheterization. Not to exceed 20 minutes. |