Near Infrared Light in Paediatric Blood Drawing Centre

Study Overview
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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.

Official Title
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Impact of Near Infrared Light in Paediatric Blood Drawing Centre on Rate of First Attempt Success and Time of Procedure

Conditions
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Blood Drawing Procedure

Intervention / Treatment
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* Device: VeinViewer®
* Procedure: Usual care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: subjects accessing the outpatient blood-drawing service Exclusion Criteria: application of topical anaesthetic cream

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VeinViewer® group<br>Use of near infrared light to perform blood draw (VeinViewer®) | Device: VeinViewer®<br>* 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<br>|
| Active Comparator: Usual care group<br>Blood drawing performed traditionally | Procedure: Usual care<br>* The blood drawing is performed traditionally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to perform the procedure | In seconds, from the placement of the tourniquet until the blood flows in the needle | Intraprocedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success at first attempt | Percentage of success at first attempt | Intraprocedural | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, blood drawing procedure, near Infrared light