Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement

Study Overview
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Brief Summary
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The objective of this project is to define the effectiveness and therefore the role of NIR vein finders in adult patients with difficult peripheral venous access. The specific objective of the proposed randomized controlled trial is to test the clinical success rate of placing peripheral venous catheters in 'difficult' access patients using traditional peripheral venous catheter placement compared to two established methods utilizing NIR vein imaging. The investigators hypothesize that the capability to successfully place lasting peripheral venous catheters is increased with the adjunct of the imaging technology, reducing the number of failed needle sticks, reducing the number of peripheral venous catheters placed throughout a patient's hospital stay, and reducing the need for more invasive catheters such as PICC lines.

Detailed Description
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The efficacy of NIR vein finders beyond the first line approach, particularly in patients that have failed conventional peripheral venous access methods or in patients that are expected to be a difficult stick, is not established. Conflicting results have been reported in the pediatric literature regarding the subjective benefit of NIR light devices in patients with perceived difficult peripheral intravenous access. In addition, knowledge about the efficacy of these devices in the adult inpatient setting is mostly unknown. The aim of the present study is to address these knowledge gaps.

Official Title
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The Efficacy of Near-Infrared Vein Imaging for the Success of Placing Peripheral Venous Catheters in Adults With Difficult Venous Access

Conditions
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Catheterization, Peripheral

Intervention / Treatment
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* Device: Near Infrared Vein Imaging
* Other: Conventional IV placement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: non-pediatric in-hospital patients (≥15 years of age, inpatient and outpatient setting) willing to provide research authorization scheduled and consented to undergo peripheral venous cannulation of one of the upper extremities to be performed by one of the members of the Vascular Access Team determined to be a difficult peripheral venous access defined by one of the following criteria in alignment to the A-DIVA scale to be assessed by one of the members of the Vascular Access Team [8]: failed inspection for more than one visible or palpable suitable vein through conventional methods failed at least one attempt of peripheral venous cannulation through any methods history of difficult peripheral venous access greatest diameter of target vein less than 3mm determined by conventional methods Exclusion Criteria: clinical contraindication for placement of peripheral venous catheter, including: severe bilateral upper extremity edema severe bilateral upper extremity skin burn severe bilateral upper extremity cellulitis history of bilateral axillary lymphadenectomy known severe cardiovascular or pulmonary compromise demanding minimization of procedure time, such as: severe shock with severe cardiovascular instability active CPR major uncontrolled hemorrhage any condition for which the primary healthcare provider is requesting emergent venous access scheduled PICC or midline catheter placement non-English-speaking patients if an interpreter is not available prisoner and any individual involuntarily confined or detained in a penal institution impaired capacity to make informed medical decisions

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional Method<br>Placement of peripheral venous catheter using conventional methods | Other: Conventional IV placement<br>* IV placement utilizing conventional methods<br>|
| Experimental: VeinViewer Visualization Only<br>Use of a VeinViewer to visualize the most suitable target. Once the target has been identified and marked, the device will be placed aside and the peripheral venous catheter will be placed using conventional methods | Device: Near Infrared Vein Imaging<br>* Use of NI vein imaging device for visualization of veins during peripheral IV placement<br>* Other names: VeinViewer Flex;Other: Conventional IV placement<br>* IV placement utilizing conventional methods<br>|
| Experimental: Constant Imaging with VeinViewer<br>Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer | Device: Near Infrared Vein Imaging<br>* Use of NI vein imaging device for visualization of veins during peripheral IV placement<br>* Other names: VeinViewer Flex;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Initial IV Placement | Rate of successful initial placement of a peripheral venous catheter (investigators have up to 30 minutes or ONE attempt before the study allows for change of technique to the preference of the Vascular Access Team member) | up to 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Near-Infrared Vein Imaging, Difficult Venous Access