An interventional study of Zonare and Veinviewer in Vascular Access Complication, sponsored by University of Maryland, Baltimore. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-12.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Treatment
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.
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.
University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients with impaired cognition and not able to consent, these patients are :
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
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.
Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.
Operator's time
time from equipment-in-room to successful aspiration of 3ml of blood
Time frame: up to 40 minutes
Number of first successful attempts
operators have up to 40 minutes or 3 attempts.
Time frame: 40 minutes
Number of failures
operators have up to 40 minutes or 3 attempts prior to patients crossing over or requiring a rescue modality
Time frame: 40 minutes
IV size
operators have up to 40 minutes or 3 attempts to establish IV from 18 to 24 gauge
Time frame: 40 minutes
Patient satisfaction
after completion of IV cannulation
Time frame: up to 40 minutes
Patient's perception of pain
after completion of IV cannulation
Time frame: up to 40 minutes
ED length of stay
Length of stay for discharged patients.
Time frame: 24 hours
hospital length of stay for admitted patient
Length of stay for admitted patients
Time frame: 30 days
Cannulation time
time from applying tourniquet to successful aspiration of 3ml of blood.
Time frame: 40 minutes
Number of failure to cannulate
operators have up to 40 minutes or 3 attempts.
Time frame: 40 minutes
Plan to share: No
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University of Maryland, Baltimore