Ultrasound vs Veinviewer in Patients With Difficulty IV Access

Not Applicable

Active, not recruiting

• Conditions: Vascular Access Complication
• Interventions: Device: Veinviewer; Device: Zonare

• Registration Number: NCT02618252
• Lead Sponsor: University of Maryland, Baltimore

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-27
• Study First Posted: 2015-12-01
• Study Start: 2016-08
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-02
• Last Update Posted: 2024-03-05
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 216

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)

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Veinviewer	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.
Zonare	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.

Primary Outcome Measures

Name	Time	Method
Operator's time	up to 40 minutes	time from equipment-in-room to successful aspiration of 3ml of blood

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States