Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-22

Study Completion Date

2020-04-01

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.

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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.

Conditions

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Catheterization, Peripheral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Conventional Method

Placement of peripheral venous catheter using conventional methods

Group Type ACTIVE_COMPARATOR

Conventional IV placement

Intervention Type OTHER

IV placement utilizing conventional methods

VeinViewer Visualization Only

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

Group Type EXPERIMENTAL

Near Infrared Vein Imaging

Intervention Type DEVICE

Use of NI vein imaging device for visualization of veins during peripheral IV placement

Conventional IV placement

Intervention Type OTHER

IV placement utilizing conventional methods

Constant Imaging with VeinViewer

Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer

Group Type EXPERIMENTAL

Near Infrared Vein Imaging

Intervention Type DEVICE

Use of NI vein imaging device for visualization of veins during peripheral IV placement

Interventions

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Near Infrared Vein Imaging

Use of NI vein imaging device for visualization of veins during peripheral IV placement

Intervention Type DEVICE

Conventional IV placement

IV placement utilizing conventional methods

Intervention Type OTHER

Other Intervention Names

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VeinViewer Flex

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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes