Central Venous Catheterization Techniques in Neonates

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 Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.

Official Title
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Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger

Conditions
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Catheterization, Central Venous

Intervention / Treatment
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* Device: Ultrasound
* Other: General anesthesia


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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Minimum Age: 1 Day
Maximum Age: 1 Month

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Seldinger<br>Use a 23 gauge introducer needle for ultrasound-guided central venous catheterization | Device: Ultrasound<br>* Ultrasound-guided central venous catheterization in internal jugular vein<br>Other: General anesthesia<br>* Scheduled operation under general anesthesia<br>|
| Experimental: Modified Seldinger<br>Use a 22 gauge Angiocath Plus catheter for ultrasound-guided central venous catheterization | Device: Ultrasound<br>* Ultrasound-guided central venous catheterization in internal jugular vein<br>Other: General anesthesia<br>* Scheduled operation under general anesthesia<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 or angiocatheter 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 or angiocatheter and flashback of blood, an expected average of 30 seconds | 
| Time to guide wire insertion |  | Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds | 
| Total time to central venous catheterization |  | Interval between skin penetration of the needle or angiocatheter 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 or angiocatheter after guide wire insertion, an expected average of 90 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infant, Newborn, Ultrasonography