Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children

Study Overview
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Brief Summary
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The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.

Official Title
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Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials

Conditions
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Catheterization, Central Venous

Intervention / Treatment
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* Device: Flexible tip straight guidewire
* Device: J-tip


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: surgery under general anesthesia require central venous catheterization Exclusion Criteria: central vein anomaly hematoma in central vein catheterization site infection

Ages Eligible for Study
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Maximum Age: 6 Months

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Flexible tip straight guidewire<br> | Device: Flexible tip straight guidewire<br>* Use a flexible tip straight guidewire for ultrasound-guided central venous catheterization<br>|
| Experimental: J-tip guidewire<br> | Device: J-tip<br>* Use a J tip straight guidewire for ultrasound-guided central venous catheterization<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First successful central venous catheterization rate |  | Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first puncture of central vein |  | Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds | 
| Time to guide wire insertion |  | Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds | 
| Total time to central venous catheterization |  | Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes | 
| Number of central vein puncture trial |  | up to 5 times, an expected average observation time of 30 seconds | 
| Number of guide wire insertion trial |  | up to 5 times, an expected average observation time of 90 seconds | 
| First successful central vein puncture rate |  | Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds | 
| First successful guide wire insertion rate |  | Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds |