Accuvein Versus Standard Care for Intravenous Cannulation Procedure in Children (AVEn)

Peripheral Intravenous Cannulation in Children With Difficult Vein Access : Randomized Study Comparing Accuvein®400 Versus Standard Care

Peripheral intravenous cannulation is one of the most common procedures performed in children admitted to hospital. It is a painful and anxiety-provoking gesture for children with possible memorization of the pain even more present for patients with chronic pathology. Nevertheless, this care is essential to administer the treatments.

The cannulation is usually set up by the observation and touching of the veins by the nurse. However, this technique is often insufficient in young children and especially infants because they have a higher thickness adipose tissue. Their veins are of small caliber, hardly visible and palpable which increases the probability of a failure of the insertion of the catheter at the first attempt.

In the literature, different techniques are mentioned to promote the visualization of veins and thus the insertion of cannulation. The AccuVein®400 (AV400) system uses an infrared laser beam to project the image of superficial veins to the skin. In adults, AV400 has been shown to improve the success rate of insertion cannulation when venous capital is precarious. The question now arises as to whether this tool could be of interest to children who are particularly difficult to assist cannulation, especially the youngest of them.

Investigator hypothesize that AV400 could bring a benefit to the placement of cannulation, in the child with a venous capital difficult to catheterize and thus increase the success of the cannulation at the first attempt.

Study Overview

• Status: Unknown
• Conditions: Vascular Access
• Intervention / Treatment: Other: Standard care; Device: Accuvein®400

Detailed Description

Children admitted to pediatric emergencies, pediatric day hospitals and the general pediatric ward, who are less than 3 years old and whose care requires the placement of a cannulation will be identified by the caregivers as potentially included.

The DIVA score will be carried out by the nurse who takes care of the child thanks to the dedicated form. If the child has an Emla® patch, this score will be achieved after removing the patch. The nurse that will achieve the score will be the same that will pose the intravenous cannulation. Children with an assessment score <4 will not be included in the study but will still be counted.

The nurse must perform the randomization by inquiring about the randomization week: standard method or AV400 method.

The information will be made to the parents and the information form given. The parents' consent regarding the care of their child will be collected by the same nurse.

The means of prevention of pain and distraction will be set up in box with the nurse and / or the auxiliary childcare and the parents. Peripheral intravenous cannulation will be performed by the nurse in collaboration with the auxiliary childcare.

Caregivers and parents will evaluate the care. The documents concerning the practical realization of the study will be grouped together and made available in each service in dedicated bins.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Recruiting
    • CHU Clermont-Ferrand
    • Principal Investigator: Etienne MERLIN
    • Sub-Investigator: Alexandra USCLADE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 day to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Child under 3 years old (male or female) managed at the University Hospital of Clermont-Ferrand with an indication of the placement of a peripheral intravenous access,
• Represented by a person having parental authority,
• Parents or holder of parental authority capable of giving their consent to the study.

Exclusion Criteria:

• Need for urgent medical care
• Care practiced by a student nurse or pediatric nurse
• Refusal of the child or the holder of parental authority.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard care; visualization and palpation	Other: Standard care; The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation
Experimental: Accuvein; system uses an infrared laser beam to project the image of superficial veins to the skin	Device: Accuvein®400; The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
successful of cannulation at first attempt	Percentage of children whose peripheral intravenous cannulation, at first attempt, is successful.	At day 1 (at the moment of peripheral intravenous cannulation)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required to install peripheral intravenous cannulation with AV400 and with the standard method	time in minute for peripheral intravenous cannulation	at day 1 (at the moment of peripheral intravenous cannulation)
effectiveness of the care by the nurse and the parents thanks	Score regarding the effectiveness of the care by the nurse and the parents thanks to the Lickert scale 5 points (from "not convinced at all" to "very convinced")	at day 1 (at the moment of peripheral intravenous cannulation)
pain assessment during insertion intravenous cannulation	Score regarding pain during insertion intravenous cannulation by an hetero scale of pain assessment : FLACC (Face Legs Activity Cry Consolability). Validated scale for acute pain during a care for children from 0 to 7 years	at day 1 (at the moment of peripheral intravenous cannulation)
Success rate according to the cannulation installation site	percentage of successful of cannulation according to the cannulation installation site	at day 1 (at the moment of peripheral intravenous cannulation)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Etienne MERLIN, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2018
• Primary Completion (Anticipated): February 1, 2020
• Study Completion (Anticipated): February 1, 2020

Study Registration Dates

• First Submitted: January 30, 2018
• First Submitted That Met QC Criteria: February 8, 2018
• First Posted (Actual): February 9, 2018

Study Record Updates

• Last Update Posted (Actual): February 9, 2018
• Last Update Submitted That Met QC Criteria: February 8, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: children; Peripheral intravenous cannulation; near-infrared light
• Other Study ID Numbers: CHU-374; 2017-A02975-49 (Other Identifier: 2017-A02975-49)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No