Pediatric DisorderNCT02381392
A Comparison of Accuvein to Standard IV Access in Children 0 to 24 Months of Age in the Pediatric ED
A study testing Accuvein AV400 in people with Pediatric Disorder, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Disorder
- What is being tested?
- Accuvein AV400
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 19 Nov 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Any pediatric emergency department patient age 0-24 months who requires intravenous access. Patients requiring emergent resuscitation will not be included.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harbor-UCLA Medical Center
Torrance, California, 90509
About this study
Official title: A Comparison of Accuvein to Standard Intravenous Access in Children 0 to 24 Months of Age in the Pediatric Emergency Department
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.
Read more
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.
Read the 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.
- Conditions
- Pediatric Disorder
- Being tested
- Accuvein AV400
- Keywords
- emergency medicine, infrared, intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accuvein AV400Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Intravenous access attempts during the current emergency department visit only, average of 60 minutes
Secondary outcomes (4)
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).
Measured: 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
Measured: 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.
Measured: 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.
Measured: Intravenous access attempts during the current emergency department visit only, average of 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startAug 2014
- Primary completion19 Nov 2016
- Study completion19 Nov 2016
Why it stopped: Insufficient enrollment, investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention group using Accuvein, Control group standard care
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kelly Young, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Kelly Young, MD, MS, Principal investigator, Harbor-UCLA Department of Emergency MedicineJoelle Donofrio, DO, Study director, Harbor-UCLA Department of Emergency Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381392
- Sponsor's protocol ID
- 21283-01
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2015
- Last updated
- 23 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Accuvein to Standard Intravenous Access in Children 0 to 24 Months of Age in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT02381392
- Acronym / sponsor ID
- 21283-01
- Conditions
- Pediatric Disorder
- Keywords
- emergency medicine, infrared, intravenous
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient enrollment, investigator left institution
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- 19 Nov 2016 (actual)
- Study completion
- 19 Nov 2016 (actual)
- First posted
- 6 Mar 2015 (estimated)
- Results
- Posted 23 Apr 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intervention group using Accuvein, Control group standard care
| Arm | Type | Receives |
|---|---|---|
| AV400 | Experimental | Device: Accuvein AV400The 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. |
| 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. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Any pediatric emergency department patient age 0-24 months who requires intravenous access. Patients requiring emergent resuscitation will not be included.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accuvein AV400This 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. | Device | AV400 |
Primary outcome
First Attempt Success at Intravenous Access
Time frame: Intravenous access attempts during the current emergency department visit only, average of 60 minutes
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.
4 secondary outcomes
Median Number of Intravenous Attempts
Time frame: Intravenous access attempts during the current emergency department visit only, average of 60 minutes
Parent Satisfaction (Likert Scale)
Time frame: Intravenous access attempts during the current emergency department visit only, average of 60 minutes
Nursing Satisfaction (Likert Scale)
Time frame: Intravenous access attempts during the current emergency department visit only, average of 60 minutes
Success in Patients With High Difficult Intravenous Access Scores
Time frame: Intravenous access attempts during the current emergency department visit only, average of 60 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Young, MD, MS principal investigator
Harbor-UCLA Department of Emergency Medicine
Joelle Donofrio, DO study director
Harbor-UCLA Department of Emergency Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accuvein AV400 in people with Pediatric Disorder, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First Attempt Success at Intravenous Access (time frame: Intravenous access attempts during the current emergency department visit only, average of 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2018.