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

NCT02381392 | Terminated Results DMC

• 1 other identifier: 21283-01
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

emergency medicine; infrared; intravenous

Outcome Measures

Primary Outcomes (1)

• First Attempt Success at Intravenous Access

  Successful: Intravenous line successfully placed with blood able to be drawn back and fluid able to be flushed into the vein. Flashback but IV blown: blood initially successfully drawn back or seen in the syringe, but subsequently unable to flush fluid into the vein. No flashback: no blood drawn back into or seen in the syringe at all. Missing data: data not recorded regarding success or flashback.

  Intravenous access attempts during the current emergency department visit only, average of 60 minutes

Secondary Outcomes (4)

• Median Number of Intravenous Attempts

  Intravenous access attempts during the current emergency department visit only, average of 60 minutes

• Parent Satisfaction (Likert Scale)

  Intravenous access attempts during the current emergency department visit only, average of 60 minutes

• Nursing Satisfaction (Likert Scale)

  Intravenous access attempts during the current emergency department visit only, average of 60 minutes

• Success in Patients With High Difficult Intravenous Access Scores

  Intravenous access attempts during the current emergency department visit only, average of 60 minutes

Study Arms (2)

AV400

EXPERIMENTAL

The nurse will use the Accuvein AV400 to assist with intravenous access. If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter without using the device. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400.

Device: Accuvein AV400

Standard

NO INTERVENTION

The nurse will use the standard technique for intravenous access (not using the Accuvein AV400). If the nurse cannot place the catheter after 2 tries (two needle sticks into the skin) then the nurse will attempt to put in the catheter with the help of the Accuvein AV400. While the nurse is putting in the catheter, a member of the study team will record the number of tries, the type of catheter and where the catheter is successfully put in. Afterwards the parent and nurse will be surveyed on their satisfaction and the nurse will be asked specific questions about using the AV400 if they crossed over to the AV400 after two failures.

Interventions

Accuvein AV400 DEVICE

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.

AV400

Eligibility Criteria

• Age: Up to 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Any pediatric emergency department patient age 0-24 months who requires intravenous access. Patients requiring emergent resuscitation will not be included.

You may not qualify if:

• Treatment will not be delayed to consent the patient's parent. If consent cannot be obtained by the study team in a timely manner, the patient will not be eligible to be included in the study.
• Subjects who are in foster care or in the care of the state.

Sponsors & Collaborators

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

Study Sites (1)

Harbor-UCLA Medical Center

Torrance, California, 90509, United States

Location

Limitations and Caveats

Unable to complete enrollment in the study

Results Point of Contact

• Title: Kelly D. Young, MD
• Organization: Harbor-UCLA Medical Center

kyoung@emedharbor.edu

310-222-3506

Study Officials

• Kelly Young, MD, MS

  Harbor-UCLA Department of Emergency Medicine

  PRINCIPAL INVESTIGATOR

• Joelle Donofrio, DO

  Harbor-UCLA Department of Emergency Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Intervention group using Accuvein, Control group standard care

Study Record Dates

• First Submitted: February 21, 2015
• First Posted: March 6, 2015
• Study Start: August 1, 2014
• Primary Completion: November 19, 2016
• Study Completion: November 19, 2016
• Last Updated: April 23, 2018
• Results First Posted: April 23, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)