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Ultrasound vs Veinviewer in Patients With Difficulty IV Access

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: NCT02618252
Recruitment Status : Active, not recruiting
First Posted : December 1, 2015
Last Update Posted : March 3, 2023
Sponsor:
Information provided by (Responsible Party):
Quincy Tran, University of Maryland, Baltimore

Study Description
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Brief Summary:
Patients with difficulty intravenous access frequently have delay of care in emergency departments because Emergency Department (ED) personnel could not establish intravenous (IV) access for diagnostic blood test or treatment. The ultrasound machine or near-infrared devices have been used to improve this situation but no study has ever compared which machine is more efficient. This study is designed to investigate whether the ultrasound or Vein Viewer, which is a near-infrared device, is more efficient.

Condition or disease Intervention/treatment Phase
Vascular Access Complication Device: Zonare Device: Veinviewer Not Applicable

Detailed Description:

Intravenous (IV) access is important for patient care in emergency medicine as an estimate of 78% of ED patients would require more than 3 ED resources such as blood tests, medication, contrast, fluid. Care for patients with difficult intravenous access (DIVA) could be significantly delayed as it may take up to 120 minutes to establish IV access in patients with severe DIVA. Many solutions for DIVA had also been established to avoid central venous catheter insertion, including using ultrasound or near-infrared imaging systems for peripheral IV insertion.

Using ultrasound in the ED has been shown to decrease the rate of central venous catheters (CVC) insertion. However, the results from ultrasound-guided peripheral IV insertion (USGPIV) have been mixed. Among patients with DIVA, Costantino reported USGPIV required less time to successful first cannulation and fewer punctures comparing to traditional approach of landmark and palpation. However, other studies showed that USGPIV did not improve successful first attempts comparing to traditional IV insertion, and may have taken same or even longer time to successfully establish IV. USGPIV success rate requires more training for nurses and ED technicians as it is operator - dependent.

Patients have difficulty with IV access because their veins' clinical accessibility is low, for example, they are less visible or less palpable. The near-infrared imaging devices, such as Christie Digital's VeinViewer, improve this situation by using infra-red lights to make veins visible to the eyes.

Compared with routine IV insertion, near-Infra red imaging devices have been shown to increase first successful attempts and in less time in children with DIVA and improved visualization of peripheral veins. However, it did not show higher rate of successful attempts nor faster time in non-selected adults.

The efficacy of these near-infrared devices has not been established among adult patients with DIVA.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Delay of Care in Patient With Difficult IV Access: A Randomized Trial of ED Intervention
Actual Study Start Date : August 2016
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Zonare
108 patients are randomized to receive the intervention of using ultrasound machine (Zonare ZS3 machine) for IV cannulation. These patients will first undergo IV cannulation with assistance of the ultrasound machine.
 Device: Zonare
Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.
Experimental: Veinviewer
108 Patients are randomized to receive the Intervention of using the Veinviewer Flex machine for IV cannulation. These patients will first undergo IV cannulation with assistance of the Veinviewer Flex machine.
 Device: Veinviewer
Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.


Outcome Measures
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Primary Outcome Measures :
  1. Operator's time [ Time Frame: up to 40 minutes ]
    time from equipment-in-room to successful aspiration of 3ml of blood


Secondary Outcome Measures :
  1. Number of first successful attempts [ Time Frame: 40 minutes ]
    operators have up to 40 minutes or 3 attempts.

  2. Number of failures [ Time Frame: 40 minutes ]
    operators have up to 40 minutes or 3 attempts prior to patients crossing over or requiring a rescue modality

  3. IV size [ Time Frame: 40 minutes ]
    operators have up to 40 minutes or 3 attempts to establish IV from 18 to 24 gauge

  4. Patient satisfaction [ Time Frame: up to 40 minutes ]
    after completion of IV cannulation

  5. Patient's perception of pain [ Time Frame: up to 40 minutes ]
    after completion of IV cannulation

  6. ED length of stay [ Time Frame: 24 hours ]
    Length of stay for discharged patients.

  7. hospital length of stay for admitted patient [ Time Frame: 30 days ]
    Length of stay for admitted patients

  8. Cannulation time [ Time Frame: 40 minutes ]
    time from applying tourniquet to successful aspiration of 3ml of blood.

  9. Number of failure to cannulate [ Time Frame: 40 minutes ]
    operators have up to 40 minutes or 3 attempts.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who fail inspections for visible or palpable veins or
  • Patients who request Ultrasound guided peripheral IV (USGPIV)
  • patients who are oriented to self (correct last name, first name), place (correct name of hospital), time (correct day of week or month of year) and person (correct name of current president)

Exclusion Criteria:

  • Patients < 18 years of age
  • Patients with hemodynamically instability requiring rapid central access.

  • Patients with impaired cognition and not able to consent, these patients are :

    • Clinically intoxicated patients, as defined by primary team.
    • Patients who family reported as "confused", "confusion", "altered mental status."
    • Patients who is not oriented x 4 as above
  • Patients who do not speak English.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT02618252


Locations
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United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore
Investigators
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Principal Investigator: Quincy Tran, MD, PhD University of Maryland
More Information
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Publications:

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Responsible Party: Quincy Tran, Assosciate Professor, University of Maryland, Baltimore
ClinicalTrials.gov Identifier: NCT02618252    
Other Study ID Numbers: HP-00065438
First Posted: December 1, 2015    Key Record Dates
Last Update Posted: March 3, 2023
Last Verified: March 2023
Keywords provided by Quincy Tran, University of Maryland, Baltimore:
difficult IV access
ultrasound
veinviewer
near infrared device