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CatheterizationPhase 4NCT00468065

VeinViewer Assisted Intravenous Catheter Placement in the Pediatric Emergency Department

A Phase 4 study testing VeinViewer in people with Catheterization, run by Lifespan at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this study is to evaluate the effectiveness of the VeinViewer® near infrared device to facilitate the placement of intravenous catheters in children who require intravenous cannulation in the pediatric emergency department. Read more about this study

Who is it for?
Ages Up to 17 years
Conditions the study is for
Catheterization
What is being tested?
VeinViewer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Apr 2007to Dec 2008
Phase
Phase 4
Are there results?
None posted in the registry

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 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Subjects must be children between the ages of 8-17 who present to the pediatric emergency department and require intravenous cannulation as part of their regular care
  • Both the child and the parent/guardian must be English-speaking
  • Both the child and the parent/guardian must be comfortable with the experimental protocol as explained to them by the study investigator or a research assistant
  • The parent/guardian must be able to understand and sign informed consent and a HIPAA form
  • The child must provide assent
  • The child must demonstrate understanding of the 100mm standard Visual Analog Scale

Who cannot join

  • Participants must not have:
  • Need for an emergent IV

Trial locations and contacts

1 site in 1 country.

Bruce M Becker, MD contact

401-444-6654

bbecker@lifespan.org

Laura Chapman Chapman, MD contact

401-444-6654

bbecker@lifespan.org

United States1 site, 1 recruiting
  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903

    Bruce M Becker, MD, 401-444-6654, bbecker@lifespan.org

    Recruiting

Other trials in United States

About this study

The objective of this study is to evaluate the effectiveness of the VeinViewer® near infrared device to facilitate the placement of intravenous catheters in children who require intravenous cannulation in the pediatric emergency department. This clinical protocol is designed to determine whether using the VeinViewer increases the ease and efficiency of IV cannulation (as perceived by the operator), decreases the time to effective cannulation, decreases the number of sticks and extravasations, and decreases the child's and the parents perception of the pain of IV cannulation.

Read the detailed description

Needle sticks are part of many standard treatments in the pediatric emergency department (ED) and are frequently a source of pain and anxiety for children. Intravenous catheters (IVs) have been shown to be among the leading causes of pain in hospitalized children 1 and venipucture is commonly seen as one of the most painful and frequently performed invasive procedures by nurses. 2 (Jacobson et al.) Children recording VAS pain scores in response to IV catheter placement in the Emergency Department rated the pain as 3.23/5.0 and their parent rated their children's pain as 3.4/5.0. 3 (Skarbek et al.) The placement of intravenous catheters would be more efficient and less stressful if the clinician had a clear roadmap or picture highlighting the location of the vein. The lack a clear visual guide to IV placement often leads to multiple painful attempts at catheter placement as well as delays urgent in treatment ( I.V. fluid and medication administration) and increased use of human resources. The current average number of catheter punctures needed in order to achieve successful catheter placement is 2.4 with a range of 1-14. 4 ( Larue, GD ) The VeinViewer by Luminetx™ allows the clinician to clearly see the child's accessible vasculature or the lack thereof in real time, directly on the surface of the skin. The clinician can be trained to operate the VeinViewer in minutes and use does not require any additional job or skills certification. The VeinViewer is free standing and hands-free allowing the clinician the freedom to use both hands to carry out the work of placing the catheter (unlike ultrasound which requires one hand to hold the probe and the other hand to place the catheter, unless two people are available and able to coordinate their work efforts thus doubling the resources necessary for I.V. placement. The VeinViewer is non-invasive and causes no tissue damage. There is no patient contact with the device and therefore no risk of infectious disease contamination with blood products. The VeinViewer uses near-infrared light to locate subcutaneous veins and project their location onto the surface of the skin thus creating a visible roadmap for I.V catheter placement. This protocol describes a prospective, randomized, study, evaluating the effectiveness of VeinViewer in increasing the ease of intravenous cannulation in children receiving intravenous cannulation in the pediatric emergency department. The investigators hypothesize that cannulation using VeinViewerâ will require fewer sticks and will result in fewer missed or repeated IV starts, fewer extravasating ("blown vein") IV placements, increased perceived ease of placement by the operator, and decreased pain associated with the IV placement as perceived by the child, the parent, and the operator.

  1. Background Intravenous cannulation is a routine and common part of treatment for children receiving care in the Pediatric Emergency Department. Intravenous cannulation is painful and often challenging in children. Peripheral IV's are generally placed using visual and/or tactile cues. These may be minimal or deceptive in children who often have small peripheral veins and increased subcutaneous fat with opaque, elastic skin. Health care workers often struggle to place these IV's successfully making multiple sticks, infiltrating subcutaneous tissues, requiring extensive operator time, and, most importantly, causing the patient and the parent distress. A number of approaches have been tried, attempting to decrease the pain of these cannulations. Most of these involve the cutaneous application of lidocaine in an attempt to numb the skin and decrease the pain of the stick.

EMLA and more recently, LMX (lidocaine in liposomal delivery system) are effective topical agents but there is a 30 minute dwell time - inappropriate in the Emergency Medicine setting. A number of devices have been tested which decrease the barrier of the stratum corneum thus allowing the lidocaine to anesthetize the skin in 3-5 minutes. These include a hand held laser (effective but burns and pigments the skin), a small ultrasound (effective but bulky and difficult to use), and gas pressure driven powdered lidocaine (effective but not approved by the FDA yet for general sales and distribution). These devices depend on identifying the vein and then successfully cannulating the identified vein through the anestethized skin. Missed sticks force the operator to begin the anesthesia process all over again in a different site. This process is time consuming and ineffective in the ED setting.

Other centers have begun to employ ultrasound to identify the veins for peripheral cannulation to cannulate under indirect visualization. This process is difficult for small mobile pediatric veins and requires extensive operator training and practice. It also requires an extra set of operator hands when children, often less than cooperative, are involved. It is unclear that this approach will be effective in the Pediatric ED.

Vein Viewerâ is a hands off device that projects a map of the subcutaneous veins onto the surface of the skin. It allows the operator to insert the IV catheter under direct visualization. It can be used by one operator who can insert the catheter and restrain the child's arm while using the device. Direct visualization is accurate and decreases the blind sticks, missed "fishing expeditions", and extravasations of IV fluid and medication (often not benign) that can occur with IV cannulation, especially in children. Decreasing the number of sticks and the time to successful catheterization will decrease the child's and the parents perceived pain of the procedure and the operator time to effective catheterization thus increasing the efficiency of the operator and the ED in general, and speeding the initiation of therapy (IV hydration or medication). The Vein Viewer has no side effects and is visually interesting to children and parents. It has the potential to revolutionize the effectiveness and efficiency, of IV cannulation in the Pediatric Emergency Department and decrease substantially the child's and the parent's perceived pain from the procedure and fear of the procedure.

Conditions
Catheterization
Being tested
VeinViewer
Keywords
intravenous, catheter, IV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VeinViewerDevice

    Veinveiwer is used to view veins subQ

  • VeinviewerDevice

    near infrared light reveals veins subcutaneously

Study groups in NCT00468065
Study groupRoleWhat they receive
AExperimentalTO use Veinviewer to improve the effectiveness of IV starts in children
Receives: Device: VeinViewer
BNo interventionStandard approach to placing IV s in children

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to successful placement of IV by practitioner

    Measured: one hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 May 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionDec 2008 (estimated)
  4. Study completionDec 2008 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00468065
Sponsor's protocol ID
0037-07
Status last verified
Apr 2007
First submitted
27 Apr 2007
Last updated
7 May 2008
Results posted
No
Data monitoring committee
Yes

Publications

  • Chapman LL, Sullivan B, Pacheco AL, Draleau CP, Becker BM. VeinViewer-assisted Intravenous catheter placement in a pediatric emergency department. Acad Emerg Med. 2011 Sep;18(9):966-71. doi: 10.1111/j.1553-2712.2011.01155.x. Epub 2011 Aug 19.

    PubMed 21854488

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing VeinViewer in people with Catheterization, run by Lifespan 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 6 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: status not confirmed, as of the sponsor's last update on 7 May 2008. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Bruce M Becker, MD (401-444-6654, bbecker@lifespan.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to successful placement of IV by practitioner (time frame: one hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00468065, which also lists 1 linked publication.

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 7 May 2008; AzTrials last refreshed its copy on 8 Nov 2026.

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