Comparison of the Central Venous Catheter Insertion Techniques

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 thin-wall needle technique and catheter-over-the-needle technique for central venous catheterization in children.

Detailed Description
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Catheterization was performed using ultrasound with an out-of-plane approach by inserting the introducer needle (thin-wall needle technique) or Angiocath Plus™ catheter (catheter-over-the-needle technique) in 45 - 60° to the patient's skin while viewing the vein in a cross section.

Official Title
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Comparison of the Central Venous Catheter Insertion Techniques: the Thin-wall Needle Versus the Catheter-over-the-needle Technique in Children

Conditions
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Child, Surgery

Intervention / Treatment
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* Other: catheter-over-the-needle technique
* Other: Thin-wall needle technique


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

Ages Eligible for Study
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Maximum Age: 5 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Catheter-over-the-needle technique<br>to use the 22G angiocatheter for central venous catheterization | Other: catheter-over-the-needle technique<br>* using a 22 G Angiocath Plus™ catheter<br>* Other names: modified Seldinger technique;|
| Experimental: Thin-wall needle technique<br>to use the sharp hollow 23G needle for central venous catheterization | Other: Thin-wall needle technique<br>* using 18 - 21 G introducer needle<br>* Other names: Seldinger technique;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Guide-wire insertion time |  | interval between skin penetration and removal of the needle or catheter after guide wire insertion, an expected average of 80 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first puncture of central vein |  | interval between skin penetration of the needle or catheter and flashback of blood, an expected average of 25 seconds | 
| Total time of central venous catheter insertion |  | interval between skin penetration of the needle or catheter 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 25 seconds | 
| Number of guide-wire insertion trial |  | up to 5 times, an expected average observation time of 80 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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central venous catheters