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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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02618252
Enrollment
0
Registered
2015-12-01
Start date
2016-08-01
Completion date
2025-05-05
Last updated
2025-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vascular Access Complication

Keywords

difficult IV access, ultrasound, veinviewer, near infrared device

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.

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.

Interventions

DEVICEZonare

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.

Sponsors

University of Maryland, Baltimore
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Operator's timeup to 40 minutestime from equipment-in-room to successful aspiration of 3ml of blood

Secondary

MeasureTime frameDescription
Number of failures40 minutesoperators have up to 40 minutes or 3 attempts prior to patients crossing over or requiring a rescue modality
IV size40 minutesoperators have up to 40 minutes or 3 attempts to establish IV from 18 to 24 gauge
Patient satisfactionup to 40 minutesafter completion of IV cannulation
Patient's perception of painup to 40 minutesafter completion of IV cannulation
Number of first successful attempts40 minutesoperators have up to 40 minutes or 3 attempts.
hospital length of stay for admitted patient30 daysLength of stay for admitted patients
Cannulation time40 minutestime from applying tourniquet to successful aspiration of 3ml of blood.
Number of failure to cannulate40 minutesoperators have up to 40 minutes or 3 attempts.
ED length of stay24 hoursLength of stay for discharged patients.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026