Ultrasound vs Veinviewer in Patients With Difficulty IV Access

Preventing Delay of Care in Patient With Difficult IV Access: A Randomized Trial of ED Intervention

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.

Study Overview

• Status: Withdrawn
• Conditions: Vascular Access Complication
• Intervention / Treatment: Device: Zonare; Device: Veinviewer

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operator's time	time from equipment-in-room to successful aspiration of 3ml of blood	up to 40 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of first successful attempts	operators have up to 40 minutes or 3 attempts.	40 minutes
Number of failures	operators have up to 40 minutes or 3 attempts prior to patients crossing over or requiring a rescue modality	40 minutes
IV size	operators have up to 40 minutes or 3 attempts to establish IV from 18 to 24 gauge	40 minutes
Patient satisfaction	after completion of IV cannulation	up to 40 minutes
Patient's perception of pain	after completion of IV cannulation	up to 40 minutes
ED length of stay	Length of stay for discharged patients.	24 hours
hospital length of stay for admitted patient	Length of stay for admitted patients	30 days
Cannulation time	time from applying tourniquet to successful aspiration of 3ml of blood.	40 minutes
Number of failure to cannulate	operators have up to 40 minutes or 3 attempts.	40 minutes

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Investigators: Principal Investigator: Quincy Tran, MD, PhD, University of Maryland

Publications and helpful links

General Publications

• Kim MJ, Park JM, Rhee N, Je SM, Hong SH, Lee YM, Chung SP, Kim SH. Efficacy of VeinViewer in pediatric peripheral intravenous access: a randomized controlled trial. Eur J Pediatr. 2012 Jul;171(7):1121-5. doi: 10.1007/s00431-012-1713-9. Epub 2012 Mar 14.
• Au AK, Rotte MJ, Grzybowski RJ, Ku BS, Fields JM. Decrease in central venous catheter placement due to use of ultrasound guidance for peripheral intravenous catheters. Am J Emerg Med. 2012 Nov;30(9):1950-4. doi: 10.1016/j.ajem.2012.04.016. Epub 2012 Jul 15.
• Bauman M, Braude D, Crandall C. Ultrasound-guidance vs. standard technique in difficult vascular access patients by ED technicians. Am J Emerg Med. 2009 Feb;27(2):135-40. doi: 10.1016/j.ajem.2008.02.005.
• 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.
• 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.
• 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.
• 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.
• Teismann NA, Knight RS, Rehrer M, Shah S, Nagdev A, Stone M. The ultrasound-guided "peripheral IJ": internal jugular vein catheterization using a standard intravenous catheter. J Emerg Med. 2013 Jan;44(1):150-4. doi: 10.1016/j.jemermed.2012.02.044. Epub 2012 May 11.
• 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.
• 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.
• Shokoohi H, Boniface K, McCarthy M, Khedir Al-tiae T, Sattarian M, Ding R, Liu YT, Pourmand A, Schoenfeld E, Scott J, Shesser R, Yadav K. Ultrasound-guided peripheral intravenous access program is associated with a marked reduction in central venous catheter use in noncritically ill emergency department patients. Ann Emerg Med. 2013 Feb;61(2):198-203. doi: 10.1016/j.annemergmed.2012.09.016. Epub 2012 Nov 7.
• Stein J, George B, River G, Hebig A, McDermott D. Ultrasonographically guided peripheral intravenous cannulation in emergency department patients with difficult intravenous access: a randomized trial. Ann Emerg Med. 2009 Jul;54(1):33-40. doi: 10.1016/j.annemergmed.2008.07.048. Epub 2008 Sep 27.
• 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.
• 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.
• Sebbane M, Claret PG, Lefebvre S, Mercier G, Rubenovitch J, Jreige R, Eledjam JJ, de La Coussaye JE. Predicting peripheral venous access difficulty in the emergency department using body mass index and a clinical evaluation of venous accessibility. J Emerg Med. 2013 Feb;44(2):299-305. doi: 10.1016/j.jemermed.2012.07.051. Epub 2012 Sep 13.
• Hess HA. A biomedical device to improve pediatric vascular access success. Pediatr Nurs. 2010 Sep-Oct;36(5):259-63.
• 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.
• Aulagnier J, Hoc C, Mathieu E, Dreyfus JF, Fischler M, Le Guen M. Efficacy of AccuVein to facilitate peripheral intravenous placement in adults presenting to an emergency department: a randomized clinical trial. Acad Emerg Med. 2014 Aug;21(8):858-63. doi: 10.1111/acem.12437.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2016
• Primary Completion (Actual): May 5, 2025
• Study Completion (Actual): May 5, 2025

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 27, 2015
• First Posted (Estimated): December 1, 2015

Study Record Updates

• Last Update Posted (Estimated): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 8, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: ultrasound; difficult IV access; veinviewer; near infrared device
• Other Study ID Numbers: HP-00065438

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