Ultrasound vs Veinviewer in Patients With Difficulty IV Access

NCT02618252 | Withdrawn FDA Device

• 1 other identifier: HP-00065438
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Vascular Access Complication

Keywords

difficult IV access; ultrasound; veinviewer; near infrared device

Outcome Measures

Primary Outcomes (1)

• Operator's time

  time from equipment-in-room to successful aspiration of 3ml of blood

  up to 40 minutes

Secondary Outcomes (9)

• Number of first successful attempts

  40 minutes

• Number of failures

  40 minutes

• IV size

  40 minutes

• Patient satisfaction

  up to 40 minutes

• Patient's perception of pain

  up to 40 minutes

Study Arms (2)

Zonare

EXPERIMENTAL

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

Veinviewer

EXPERIMENTAL

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

Interventions

Zonare DEVICE

Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.

Zonare

Veinviewer DEVICE

Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.

Veinviewer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (19)

• Tanabe P, Gimbel R, Yarnold PR, Adams JG. The Emergency Severity Index (version 3) 5-level triage system scores predict ED resource consumption. J Emerg Nurs. 2004 Feb;30(1):22-9. doi: 10.1016/j.jen.2003.11.004.

  PMID: 14765078 BACKGROUND

• Witting MD. IV access difficulty: incidence and delays in an urban emergency department. J Emerg Med. 2012 Apr;42(4):483-7. doi: 10.1016/j.jemermed.2011.07.030. Epub 2011 Dec 2.

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• Maiocco G, Coole C. Use of ultrasound guidance for peripheral intravenous placement in difficult-to-access patients: advancing practice with evidence. J Nurs Care Qual. 2012 Jan-Mar;27(1):51-5. doi: 10.1097/NCQ.0b013e31822b4537.

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  PMID: 22579025 BACKGROUND

• Weiner SG, Sarff AR, Esener DE, Shroff SD, Budhram GR, Switkowski KM, Mostofi MB, Barus RW, Coute RA, Darvish AH. Single-operator ultrasound-guided intravenous line placement by emergency nurses reduces the need for physician intervention in patients with difficult-to-establish intravenous access. J Emerg Med. 2013 Mar;44(3):653-60. doi: 10.1016/j.jemermed.2012.08.021. Epub 2012 Oct 25.

  PMID: 23103067 BACKGROUND

• de Graaff JC, Cuper NJ, Mungra RA, Vlaardingerbroek K, Numan SC, Kalkman CJ. Near-infrared light to aid peripheral intravenous cannulation in children: a cluster randomised clinical trial of three devices. Anaesthesia. 2013 Aug;68(8):835-45. doi: 10.1111/anae.12294. Epub 2013 Jun 14.

  PMID: 23763614 BACKGROUND

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  PMID: 23141920 BACKGROUND

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  PMID: 22795988 BACKGROUND

• Costantino TG, Parikh AK, Satz WA, Fojtik JP. Ultrasonography-guided peripheral intravenous access versus traditional approaches in patients with difficult intravenous access. Ann Emerg Med. 2005 Nov;46(5):456-61. doi: 10.1016/j.annemergmed.2004.12.026.

  PMID: 16271677 BACKGROUND

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  PMID: 18824276 BACKGROUND

• Liu YT, Alsaawi A, Bjornsson HM. Ultrasound-guided peripheral venous access: a systematic review of randomized-controlled trials. Eur J Emerg Med. 2014 Feb;21(1):18-23. doi: 10.1097/MEJ.0b013e328363bebc.

  PMID: 23880981 BACKGROUND

• Witting MD, Schenkel SM, Lawner BJ, Euerle BD. Effects of vein width and depth on ultrasound-guided peripheral intravenous success rates. J Emerg Med. 2010 Jul;39(1):70-5. doi: 10.1016/j.jemermed.2009.01.003. Epub 2009 Mar 9.

  PMID: 19272730 BACKGROUND

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  PMID: 21067078 BACKGROUND

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  PMID: 22415409 BACKGROUND

• Sun CY, Lee KC, Lin IH, Wu CL, Huang HP, Lin YY, Hsu YF, Yu HR. Near-infrared light device can improve intravenous cannulation in critically ill children. Pediatr Neonatol. 2013 Jun;54(3):194-7. doi: 10.1016/j.pedneo.2012.12.012. Epub 2013 Feb 1.

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• Fields JM, Piela NE, Au AK, Ku BS. Risk factors associated with difficult venous access in adult ED patients. Am J Emerg Med. 2014 Oct;32(10):1179-82. doi: 10.1016/j.ajem.2014.07.008. Epub 2014 Jul 30.

  PMID: 25171796 BACKGROUND

Study Officials

• Quincy Tran, MD, PhD

  University of Maryland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assosciate Professor

Study Record Dates

• First Submitted: November 4, 2015
• First Posted: December 1, 2015
• Study Start: August 1, 2016
• Primary Completion: May 5, 2025
• Study Completion: May 5, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)