NCT03427723

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2018

Completed
1 day until next milestone

Study Start

First participant enrolled

January 31, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 9, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

February 9, 2018

Status Verified

February 1, 2018

Enrollment Period

2 years

First QC Date

January 30, 2018

Last Update Submit

February 8, 2018

Conditions

Vascular Access

Keywords

Peripheral intravenous cannulationchildrennear-infrared light

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Time required to install peripheral intravenous cannulation with AV400 and with the standard method

    at day 1 (at the moment of peripheral intravenous cannulation)

  • effectiveness of the care by the nurse and the parents thanks

    at day 1 (at the moment of peripheral intravenous cannulation)

  • pain assessment during insertion intravenous cannulation

    at day 1 (at the moment of peripheral intravenous cannulation)

  • Success rate according to the cannulation installation site

    at day 1 (at the moment of peripheral intravenous cannulation)

Study Arms (2)

Standard care

ACTIVE COMPARATOR

visualization and palpation

Other: Standard care

Accuvein

EXPERIMENTAL

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

Device: Accuvein®400

Interventions

Accuvein®400DEVICE

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

Accuvein
Standard careOTHER

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

Standard care

Eligibility Criteria

Age1 Day - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Clermont-Ferrand

Clermont-Ferrand, 63003, France

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Etienne MERLIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick LACARIN

CONTACT

04 73 75 11 95placarin@chu-clermontferrand.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: accuvein versus standard
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2018

First Posted

February 9, 2018

Study Start

January 31, 2018

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

February 9, 2018

Record last verified: 2018-02

Locations

FR(1)