A Comparison of Accuvein to Standard IV Access in Children 0 to 24 Months of Age in the Pediatric ED

NCT02381392 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2018-04-23

Study results available
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Summary

Obtaining intravenous (IV) access in children under the age of 2 years is difficult, especially in the emergency department (ED) where the children can be frightened, dehydrated and ill. Often it requires multiple needle sticks and nurses to place an IV in a difficult child. In our ED the recently acquired an Accuvein AV400 device. This infrared light, like a barcode scanner, makes the veins on a child appear like roads on a map. This ideally shows the nurse where to place and direct the needle. This device is approved by the FDA to work with children and has not been shown to have any harmful effects. However, there are no studies showing whether this device helps in the difficult less than 2 year olds seen in the emergency department.

This study will be to directly compare placing an IV in a child under 2 years of age with the AV400 versus not using the device. A physician, medical student, or nurse practitioner who has been trained on how to observe nurses place IVs will enroll children who require an IV for their ED clinical care (as determined by their ED doctors). This person will consent the parents, ask the parents questions regarding the child's past medical history, and have the nurse look at the veins of the child ahead of the IV access attempt to rate the level of difficulty expected (easy, moderate, difficult). Whether the child has the IV attempt performed with or without the AV400 will be computer randomized. The nurse will attempt to place the IV, and the study staff will observe and record the number of attempts, size of the IV catheter, and location of the IV. If 2 attempts are failed, the patient will "cross over" to the other condition, that is if AV400 was being used then it will not be used, and if AV400 was not being used then it will be used. If there are 4 failed attempts at IV placement, then the child will be treated as per our department's difficult IV access protocol, which is applied to all children with difficult IV access regardless of participation in the study. After the IV placement, both the parents and the nurse will be asked several questions regarding satisfaction with use of the AV400.

No patient identifiers will be collected.

The investigators will be recruiting 260 children to determine if using the AV400 device improves the first time needle stick success from 40% to 60%.

Nursing approval for the study was obtained prior to the study.

Conditions

  • Pediatric Disorder

Interventions

DEVICE

Accuvein AV400

This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.

Sponsors & Collaborators

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    lead OTHER

Principal Investigators

  • Kelly Young, MD, MS · Harbor-UCLA Department of Emergency Medicine

  • Joelle Donofrio, DO · Harbor-UCLA Department of Emergency Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
24 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-11-19
Completion
2016-11-19

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02381392 on ClinicalTrials.gov