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Near Infrared Light in Paediatric Blood Drawing Centre

NCT ID: NCT03277092

Last Updated: 2017-11-30

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

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-02

Study Completion Date

2017-11-28

Brief Summary

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Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr.

The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.

Detailed Description

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Conditions

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Blood Drawing Procedure

Keywords

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Child, blood drawing procedure, near Infrared light

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VeinViewer® group

Use of near infrared light to perform blood draw (VeinViewer®)

Group Type EXPERIMENTAL

VeinViewer®

Intervention Type DEVICE

Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site

Usual care group

Blood drawing performed traditionally

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type PROCEDURE

The blood drawing is performed traditionally

Interventions

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VeinViewer®

Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site

Intervention Type DEVICE

Usual care

The blood drawing is performed traditionally

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* subjects accessing the outpatient blood-drawing service

Exclusion Criteria

* application of topical anaesthetic cream
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IRCCS Burlo Garofolo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Egidio Barbi, MD PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Burlo Garofolo

Locations

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IRCCS Burlo Garofolo

Trieste, , Italy

Site Status

Countries

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Italy

References

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Conversano E, Cozzi G, Pavan M, Minute M, Gortan E, Montico M, Vecchi Brumatti L, Ronfani L, Barbi E. Impact of near infrared light in pediatric blood drawing Centre on rate of first attempt success and time of procedure. Ital J Pediatr. 2018 May 25;44(1):60. doi: 10.1186/s13052-018-0501-1.

Reference Type DERIVED
PMID: 29801519 (View on PubMed)

Other Identifiers

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RC 22/17

Identifier Type: -

Identifier Source: org_study_id