Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Near-infrared Vein Imaging for Peripheral IV Placement

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05051020
Recruitment Status : Terminated (COVID epidemic)
First Posted : September 21, 2021
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Lahey Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Catheterization, Peripheral Device: Near Infrared Vein Imaging Other: Conventional IV placement Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Efficacy of Near-Infrared Vein Imaging for the Success of Placing Peripheral Venous Catheters in Adults With Difficult Venous Access
Actual Study Start Date : January 22, 2020
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


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
Device: Near Infrared Vein Imaging
Use of NI vein imaging device for visualization of veins during peripheral IV placement
Other Name: VeinViewer Flex

Other: Conventional IV placement
IV placement utilizing conventional methods

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 Name: VeinViewer Flex




Primary Outcome Measures :
  1. Successful Initial IV Placement [ Time Frame: 15 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)


Secondary Outcome Measures :
  1. Number Required Needle Sticks [ Time Frame: 15 minutes ]
    Number of required needle sticks before successful placement of a peripheral venous catheter

  2. Method Ultimately Resulting in Successful IV Placement [ Time Frame: 15 minutes ]
    Rate of success for each method of peripheral IV placement. This includes conventional methods with no near-infrared imaging device usage, use of the near-infrared device for visualization and target marking only and placement of IV via conventional methods, or use of near-infrared device for constant visualization during vein visualization and IV placement.

  3. Vein Visualization [ Time Frame: 15 minutes ]
    Number of visible veins suitable for cannulation (each continuous vein will be counted as one cannulation site)

  4. Gauge Size [ Time Frame: 15 minutes ]
    IV catheter gauge size utilized after completion of IV cannulation

  5. Target Vein Location [ Time Frame: 15 minutes ]
    Target vein location (bend of the elbow, forearm, back of hand, other) and side of extremity (right vs. left)

  6. Use of Warming of Arms Before IV Placement [ Time Frame: 15 minutes ]
    This measure looks at whether or not warming of the arms was performed before peripheral IV placement to aid in vein visualization.

  7. Length of Procedure [ Time Frame: 15 minutes ]
    Procedure time

  8. Complications [ Time Frame: 3 days ]
    Rates of procedure associated complications

  9. Impact of Experience [ Time Frame: 15 minutes ]
    Vascular Access Team member experience (years in practice).

  10. Patient Subjective Experience of Peripheral IV Placement [ Time Frame: 15 minutes ]
    Patient survey on IV placement satisfaction. Satisfaction rating from Very Satisfied to Very Dissatisfied.

  11. Vascular Access Team member Subjective Experience of Peripheral IV Placement [ Time Frame: 15 minutes ]
    Vascular Access Team member survey regarding difficulty of vein visualization and subsequent IV placement. Difficulty of IV visualization and placement rated from Very Difficult to Very Easy.

  12. Vascular Access Team member Subjective Experience with Vein Imaging Device [ Time Frame: 15 minutes ]
    Vascular Access Team member survey regarding helpfulness of the near-infrared vein imaging device if used. If vein imaging device was used, asked if it was helpful and rated from Strongly Agree to Strongly Disagree.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05051020


Locations
Layout table for location information
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Investigators
Layout table for investigator information
Principal Investigator: Thomas Schnelldorfer, MD Lahey Clinic
Publications:

Layout table for additonal information
Responsible Party: Lahey Clinic
ClinicalTrials.gov Identifier: NCT05051020    
Other Study ID Numbers: 0001
First Posted: September 21, 2021    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Keywords provided by Lahey Clinic:
Near-Infrared Vein Imaging
Difficult Venous Access