Pediatric Veins Cannulation Technique

Bambino Gesù Hospital and Research Institute

Status: Completed

Conditions: Successful Vein Cannulation at First Attempt

Treatments: Device: infrared technology: Veinsite

Study type: Interventional

Funder types: Other

Identifiers

NCT02918604

AR-INNCB 11-2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 patients

Sex: All

Ages: Under 4 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

B : veinsite access

Other group

Description:

infrared technology vein access

Treatment:

Device: infrared technology: Veinsite

A: control group

Active Comparator group

Description:

conventional vein access

Treatment:

Device: infrared technology: Veinsite