Completed

NCT Number: NCT02918604

Pediatric Veins Cannulation Technique

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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Key information

Conditions

Successful Vein Cannulation at First Attempt

Age range

Up to 4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

infrared technology: Veinsite

Device

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

Primary outcomes

success of peripheral vein access positioning

Time frame: 2 year

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.

Secondary outcomes

impact of DIVA score(difficult vein access score) on time of success number of participants with treatment-related peripheral vein cannulation failure

Time frame: 2 year

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.

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2016
Study completion: 2016
First posted: Sep 29, 2016
Registry last updated: Sep 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.