Clinical trial NCT02618252: Ultrasound vs Veinviewer in Patients With Difficulty IV Access
Official title: Preventing Delay of Care in Patient With Difficult IV Access: A Randomized Trial of ED Intervention
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Vascular Access Complication
Keywords: difficult IV access
ultrasound
veinviewer
near infrared device
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2015-12-01
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Operator's time
timeFrame: up to 40 minutes
Secondary outcomes:
measure: Number of first successful attempts
timeFrame: 40 minutes
measure: Number of failures
timeFrame: 40 minutes
measure: IV size
timeFrame: 40 minutes
measure: Patient satisfaction
timeFrame: up to 40 minutes
measure: Patient's perception of pain
timeFrame: up to 40 minutes
measure: ED length of stay
timeFrame: 24 hours
measure: hospital length of stay for admitted patient
timeFrame: 30 days
measure: Cannulation time
timeFrame: 40 minutes
measure: Number of failure to cannulate
timeFrame: 40 minutes
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
Study officials:
affiliation: University of Maryland
name: Quincy Tran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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