Pediatric Veins Cannulation Technique

Not Applicable

Completed

• Conditions: Successful Vein Cannulation at First Attempt

• Registration Number: NCT02918604
• Lead Sponsor: Bambino Gesù Hospital and Research Institute

Brief Summary

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

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2016-01
• Study Completion: 2016-05
• Status Verified: 2016-09
• Study First Submitted: 2016-09-20
• Study First Submitted QC: 2016-09-27
• Last Update Submitted: 2016-09-27
• Study First Posted: 2016-09-29
• Last Update Posted: 2016-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
success of peripheral vein access positioning	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 Outcome Measures

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