Effect of Ultrasound-guided Insertion on Peripheral Catheters Related Complications.

Study Overview
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Brief Summary
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The purpose of this study is to compare the appearance of complications after the insertion of peripheral venous catheters with two different techniques (traditional and ultrasound-guided).

Detailed Description
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All patients, whose parents were informed about the study and give written informed consent, will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to visualization/palpation or ultrasound-guided peripheral catheter insertion. All participants undergo a 10 days monitoring of the catheter status.

Official Title
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Effect of Ultrasound-guided Insertion of Peripheral Catheters in the Forearm in Complications Incidence.

Conditions
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Catheter Related Complication

Intervention / Treatment
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* Procedure: Traditional Peripheral venous catheter insertion
* Procedure: Ultrasound-guided insertion of a peripheral venous catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 0 and 18 years Patients in need of a peripheral venous catheter Exclusion Criteria: Inability of insertion in both forearms (i.e. burnt, amputation) Patients in need of a central venous catheter

Ages Eligible for Study
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Maximum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants are assigned to the traditional or ultrasound-guided insertion group
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Traditional technique<br>Peripheral venous catheters inserted to the participants in this arm are inserted with a palpation/visualization guided technique in their hand, arm, foot or head. | Procedure: Traditional Peripheral venous catheter insertion<br>* Insertion of a short catheter in a peripheral vein with the help of visualization palpation<br>|
| Experimental: Ultrasound-guided technique<br>Peripheral venous catheters inserted to the participants in this arm are inserted with an ultrasound-guided technique in their forearm. | Procedure: Ultrasound-guided insertion of a peripheral venous catheter<br>* Insertion of a short catheter in a peripheral vein with the help of an ultrasound device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants presenting peripheral catheter insertion-related complications for each intervention | Peripheral insertion-related complications: phebitis, infiltration, catheter loss, obstruction | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic traits of participants presenting peripheral catheter-related complications | Age average (years) and gender (male/female) | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days | 
| The proportion of canalization aspects in peripheral catheter-related complications | Catheter size (Ga), operator experience (years), insertion site (hand/forearm/arm/foot/head), insertion ward (PICU/ER) | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days | 
| Number of participants that present immobilization of the limb in both techniques | Immobilization of the limb where the peripheral catheter is inserted (Yes/No) | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days | 
| Use of the catheter inserted in participants presenting peripheral catheter-related complications | Type of fluid infusion, antibiotic administration (Yes/No) | From catheter insertion until the date of documented complication or catheter withdrawal assessed up to 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral, ultrasound-guided