Pediatric Veins Cannulation Technique

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2016-05-31

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.

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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:

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.

Conditions

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Successful Vein Cannulation at First Attempt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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B : veinsite access

infrared technology vein access

Group Type OTHER

infrared technology: Veinsite

Intervention Type DEVICE

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

A: control group

conventional vein access

Group Type ACTIVE_COMPARATOR

infrared technology: Veinsite

Intervention Type DEVICE

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

Interventions

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infrared technology: Veinsite

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

Intervention Type DEVICE

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