Efficacy of Near-Infrared Vein Imaging for Difficult IV Placement

March 3, 2022 updated by: Lahey Clinic

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Burlington, Massachusetts, United States, 01805
        • Lahey Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventional Method
Placement of peripheral venous catheter using conventional methods
Other: Conventional IV placement
IV placement utilizing conventional methods
Experimental: 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
Other: Conventional IV placement
IV placement utilizing conventional methods
Device: Near Infrared Vein Imaging
Use of NI vein imaging device for visualization of veins during peripheral IV placement
Other Names:
  • VeinViewer Flex
Experimental: Constant Imaging with VeinViewer
Identification of the most suitable target and placement of a peripheral venous catheter under constant imaging with a VeinViewer
Device: Near Infrared Vein Imaging
Use of NI vein imaging device for visualization of veins during peripheral IV placement
Other Names:
  • VeinViewer Flex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Successful Initial IV Placement
Time Frame: up to 30 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahey Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2020

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

January 30, 2020

First Submitted That Met QC Criteria

February 7, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

March 4, 2022

Last Update Submitted That Met QC Criteria

March 3, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20193166

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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