Infra Red Vein Visualization: Efficacy vs. Standard Technique

Study Overview
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Brief Summary
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The objective of the study is to assess the efficacy of the vein visualization device AccuVein (AccuVein, Inc., Huntington, NY) in comparison to a standard technique for establishing intravenous (iv) access in the infant and toddler population (<2years)

Detailed Description
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The objective of this project is to compare the iv success rate using the FDA approved Accuvein device for vein illumination versus not using the device, for infants/toddlers undergoing surgery at Penn State Children's Hospital with an ASA physical status 1, 2, or 3. After obtaining informed consent, the infant will be randomized to the vein illuminatin or standard group based on a computer generated number.

Official Title
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A Randomized Controlled Study of Efficacy of Infra Red Vein Illumination Versus Standard Technique

Conditions
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Difficult Intravenous Access

Intervention / Treatment
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* Device: Infrared illumination


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children(<2year) undergoing anesthesia procedures at Penn State Health, Hershey Medical Center and Penn State Children's Hospital ASA physical status 1,2 or 3 Exclusion Criteria: Emergency procedures requiring anesthesia ASA physical status 4 Patients with pre existing iv access

Ages Eligible for Study
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Maximum Age: 2 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Infrared vein illumination<br>Infrared illumination of veins, using the FDA approved AccuVein device, will be used to assist in vein location when inserting an intravenous access line | Device: Infrared illumination<br>* Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.<br>|
| No Intervention: Standard Technique<br>Standard vein location techniques will be used when inserting an intravenous access line | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | Success for insertion of intravenous access line will be determined by flushability with 5 ml of sterile normal saline | When patient is in operating room and insertion of intravenous access line has been confirmed to be successful, an average of 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Attempts | The number of attempts it takes for successful insertion of the intravenous access line | When patient is in operating room and insertion of intravenous access line is performed | 
| Time to Successful Insertion | The time to successful insertion of the intravenous access line will be measured from the first time that the canula touches the skin to until successful iv access is established | When patient is in operating room and insertion of intravenous access line is performed |