Pediatric Veins Cannulation Technique

Bambino Gesù Hospital and Research Institute80 enrolled

Overview

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

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: 1. Fondazione IRCCS Istituto Neurologico "C.Besta" , Milano 2. 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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Successful Vein Cannulation at First Attempt

Interventions

infrared technology: VeinsiteDEVICE

peripheral vein access performed with Veinsite support by expert paediatric anaesthesiologists and intensivists

Eligibility

Sex: ALLMax age: 4 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 2 year

Secondary Outcomes

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.

Time frame: 2 year

Data from ClinicalTrials.gov

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