Near Infrared Light in Paediatric Blood Drawing Centre

NCT03277092 | Completed

• 1 other identifier: RC 22/17
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Blood Drawing Procedure

Keywords

Child, blood drawing procedure, near Infrared light

Outcome Measures

Primary Outcomes (1)

• Time to perform the procedure

  In seconds, from the placement of the tourniquet until the blood flows in the needle

  Intraprocedural

Secondary Outcomes (1)

• Success at first attempt

  Intraprocedural

Study Arms (2)

VeinViewer® group

EXPERIMENTAL

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

Device: VeinViewer®

Usual care group

ACTIVE COMPARATOR

Blood drawing performed traditionally

Procedure: Usual care

Interventions

VeinViewer® 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

VeinViewer® group

Usual care PROCEDURE

The blood drawing is performed traditionally

Usual care group

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• subjects accessing the outpatient blood-drawing service

You may not qualify if:

• application of topical anaesthetic cream

Sponsors & Collaborators

• IRCCS Burlo Garofolo: lead

Study Sites (1)

IRCCS Burlo Garofolo

Trieste, 34137, Italy

Location

Related Publications (1)

• 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.

  PMID: 29801519 DERIVED

Study Officials

• Egidio Barbi, MD PhD

  IRCCS Burlo Garofolo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2017
• First Posted: September 8, 2017
• Study Start: October 2, 2017
• Primary Completion: November 28, 2017
• Study Completion: November 28, 2017
• Last Updated: November 30, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)