Pediatric Veins Cannulation Technique

September 27, 2016 updated by: Emanuele Rossetti, Bambino Gesù Hospital and Research Institute

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bambino Gesù Hospital and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

September 20, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 29, 2016

Study Record Updates

Last Update Posted (Estimate)

September 29, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AR-INNCB 11-2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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