Accuvein Versus Standard Care for Intravenous Cannulation Procedure in Children

NCT ID: NCT03427723

Last Updated: 2018-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2020-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Vascular Access

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

accuvein versus standard
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard care

visualization and palpation

Group Type ACTIVE_COMPARATOR

Standard care

Intervention Type OTHER

The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation

Accuvein

system uses an infrared laser beam to project the image of superficial veins to the skin

Group Type EXPERIMENTAL

Accuvein®400

Intervention Type DEVICE

The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation

Interventions

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Accuvein®400

The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation

Intervention Type DEVICE

Standard care

The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

1 Day

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Etienne MERLIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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Chu Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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2017-A02975-49

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-374

Identifier Type: -

Identifier Source: org_study_id

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