Central Venous Catheters in Pediatric Anesthesia and Intensive Care

Study Overview
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Brief Summary
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Securing the intravenous line is one of the fundamental interventions in paediatric anaesthesia and intensive care. Central venous catheters (CVC) are indicated for long-term stay in intensive care unit (ICU), in case of circulatory instability and the need for vasopressor therapy, for hypertonic solutions administration and parenteral nutrition. The dominant method of CVC insertions is the Seldingers´ method (over the wire) and ultrasound real-time navigation in recommended. Ultrasound-guided (USG) CVC insertion however requires experience personnel and relevant training.This could be the main reason, that CVC the real-time ultrasound navigation is still not adequately implemented into the clinical practice.

Detailed Description
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After Ethics committee approval, patients indicated for CVC insertions will be included. Based on the observational design of the trial, the method of insertion (Real-time ultrasound navigation versus anatomical-based CVC insertion) will be based on operators´ decision.The indication for CVC insertion, primary planned site of insertion, USG implementation, site of actual CVC cannulation and associated complications will be recorded. The primary aim of the study was to compare the effectivity of Real-time ultrasound navigation versus anatomical-based CVC insertion in paediatric patients and the 1st percutaneous puncture success rate. The secondary aims will be the incidence of associated complications and the time form first percutaneous puncture, to definitely securing the CVC in place. The primary hypothesis is that the Ultrasound-guided CVC insertion is superior, with the higher overall success, higher first attempt success rate and with lower incidence of associated complications.

Official Title
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Central Venous Catheters in Pediatric Anesthesia and Intensive Care: Prospective Observational Trial

Conditions
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Central Line

Intervention / Treatment
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* Device: Central venous line insertion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pediatric patients within the age limit indicated for CVC insertion Exclusion Criteria: Outside the age limit

Ages Eligible for Study
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Maximum Age: 19 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric patients indicated to CVC insertion<br>Paediatric patients indicated to central venous line insertion | Device: Central venous line insertion<br>* Pediatric patients indicated to central venous line insertion<br>* Other names: Central venous line cannulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall success and first attempt success rate | The overall success rate and first attempt success rate will be evaluated between ultrasound-guided and anatomical-based navigation | During CVC insertion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications | Incidence of arterial puncture, hemothorax and/or pneumothorax incidence, incidence of CVC malposition will be recorded | 24 hours from CVC insertion | 
| Time of insertion | The time from first percutaneous puncture to CVC insertion will be monitored and evaluated between | During CVC insertion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Central line, Pediatric patient, Insertion, Cannulation