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

Study Overview
=================
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.

Detailed Description
-----------------
The investigators hypothesize that the use of the Accuvein AV400 (AV400) with intravenous access will improve the first attempt success rate in intravenous (IV) starts for patients ages 0-24 months of age by 20% as compared to the standard technique. Study Recruitment and protocol Potential subjects will be patients age 0-24 months recruited from the pediatric emergency department at Harbor-UCLA. The patients will be screened for meeting criteria of age 0-24 months, requiring IV access, not requiring emergent resuscitative access, and not being a ward of the state. Nurses who work in the pediatric emergency department and who obtain IV access in children will be solicited by members of the research team to participate in the study. All nurses who are trained to use the device will be able to participate as operators in the study. The patient will be enrolled as a subject and the data collection form will be filled out by a trained observer. The data collection form contains: trained observer level of training; blinded nursing number; randomization number; patient gender, age in months, weight, height, Fitzpatrick skin color, dehydration status, mental status, gestational age, chronic medical conditions, and hospitalizations in last two years; nurse's assessment of vein palpability, visibility, and subjective difficulty; nurse's pediatric ED experience and overall experience in years; access tool and whether crossover was utilized; IV gauge, IV access site, number of persons needed to assist, and whether access was successful. All trained observers will have undergone training to ensure reliability between observers. Once a patient has been identified as a potential subject by the trained observer and consent has been obtained, a blinded randomized manila envelope will be chosen. The data collection form will be completed by the trained observer and then the nurse will attempt first IV attempt per the arm of the study (standard versus with AV400 assistance). The patient will receive two attempts using the assigned randomized method. If 2 failed attempts, the nurse will cross arms of the study and use the other IV access method. If this fails, the standard difficult IV access pathway used by the pediatric ED will be started. Currently this pathway is started after 4 failed IV attempts. Therefore, there is no additional risk to the subject in the study. After the IV access has been successful or the difficult IV access pathway has begun, the trained observer will then ask the parent and nurse a series of questions based on a Likert scale to assess satisfaction and whether the nurse felt the AV400 helped find veins, distracted her/him from usual technique, and/or saved time. No identifying data will be collected on the nurse or subject. Trained observers will not be ordering any IV placements, labs or medications for subjects. Potential subjects will have had orders placed for IV access prior to their selection for eligibility.

Official Title
-----------------
A Comparison of Accuvein to Standard Intravenous Access in Children 0 to 24 Months of Age in the Pediatric Emergency Department

Conditions
-----------------
Pediatric Disorder

Intervention / Treatment
-----------------
* Device: Accuvein AV400


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any pediatric emergency department patient age 0-24 months who requires intravenous access. Patients requiring emergent resuscitation will not be included. Exclusion Criteria: 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.

Ages Eligible for Study
-----------------
Maximum Age: 24 Months

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention group using Accuvein, Control group standard care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AV400<br>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<br>* 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.<br>|
| No Intervention: Standard<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Number of Intravenous Attempts | To compare the median number of IV access attempts until success or escalation of therapy to the difficult IV access team between those placed with the AV400 as to those without (ie the standard technique). | Intravenous access attempts during the current emergency department visit only, average of 60 minutes | 
| Parent Satisfaction (Likert Scale) | To compare parent satisfaction using a Likert scale between use of the AV400 and the standard technique | Intravenous access attempts during the current emergency department visit only, average of 60 minutes | 
| Nursing Satisfaction (Likert Scale) | To compare nursing satisfaction using a Likert scale between use of the AV400 and the standard technique. | Intravenous access attempts during the current emergency department visit only, average of 60 minutes | 
| Success in Patients With High Difficult Intravenous Access Scores | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
emergency medicine, infrared, intravenous