Pediatric Veins Cannulation Technique

Study Overview
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Brief Summary
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multicenter, prospective and cohort study to evaluate infrared technology for identifying and and indwelling peripheral veins in 0 up to 4 years old children.

Detailed Description
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AIM OF THE STUDY The primary objective of this study is to determine the success rate at first attempt of peripheral veins cannulation in small children (<5yrs) and infants (<1yr) of Veinsite compared with traditional palpation method performed by skilled operators. The secondary objective of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure. DESIGN Prospective randomized controlled study Population It is expected to recruit 60 pediatric patients undergoing peripheral vein cannulation with known difficulties according the difficult venous access score (DIVA) (6) in the following centers: Fondazione IRCCS Istituto Neurologico C.Besta , Milano Ospedale Pediatrico Bambino Gesù, IRCCS, Roma Duration of study Patient will be followed from the day of peripheral vein cannulation till the peripheral cannula will be removed (max 3 days) in order to assess any cause of venous extravasation. The recruitment phase is supposed to be 6 months after achieving the ethical-administrative authorization.

Official Title
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Peripheral Veins Cannulation in Children Using Veinsite: a Randomized Clinical Trial

Conditions
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Successful Vein Cannulation at First Attempt

Intervention / Treatment
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* Device: infrared technology: Veinsite


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and Female children from 1 month to 5 years Of age American Society of Anesthesiologists Classification (ASA) I: without systemic disease American Society of Anesthesiologists Classification (ASA) II: moderate systemic disease American Society of Anesthesiologists Classification (ASA) III: severe systemic disease that limits normal activity, without invalidity. Scheduled for any indication of peripheral venous line placement Admission to an Intensive Care Unit, Neurosurgery ward or pediatric ward of one of the hospitals included Children whose parents (or legal tutors) have given their informed written consent Exclusion Criteria: Any contraindication for peripheral line placement Children whose parents (or legal tutors) denied their own consensus

Ages Eligible for Study
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Maximum Age: 4 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: B : veinsite access<br>infrared technology vein access | Device: infrared technology: Veinsite<br>* peripheral vein access performed with Veinsite support by expert paediatric anaesthesiologists and intensivists<br>|
| Active Comparator: A: control group<br>conventional vein access | Device: infrared technology: Veinsite<br>* peripheral vein access performed with Veinsite support by expert paediatric anaesthesiologists and intensivists<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success of peripheral vein access positioning | to determine the success rate at first attempt of peripheral veins cannulation in small children (<5yrs) and infants (<1yr) of Veinsite compared with traditional palpation method performed by skilled operators. | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact of DIVA score(difficult vein access score) on time of success number of participants with treatment-related peripheral vein cannulation failure | of this study is to determine the time to cannulation using the two techniques, the difference in visualized veins using the Veinsite or the direct visualization and palpation of the patients' skin, cannula indwelling time and complications related to the procedure. | 2 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral vein access, infrared, pediatric