VeinViewer for Peripheral IV Placement in Children With Difficult Intravenous (IV) Access
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00357799|
Recruitment Status : Completed
First Posted : July 28, 2006
Last Update Posted : August 24, 2011
Hypothesis: The first attempt success rate for peripheral IV insertion for children with difficult IV access (difficult IV access [DIVA] score ≥ 4) by nurses using the VeinViewer guided technique is better than conventional method of IV placement.
- To investigate if use of the VeinViewer can improve the success of peripheral IV placement in children with difficult IV access
- To validate the DIVA score
Design: Prospective randomized controlled trial/Convenience sample
Subjects: Children (0-18) presenting to the emergency department who require an IV as determined by examining physician and with a DIVA score ≥ 3 during times when VeinViewer machine is available and a VeinViewer trained participating nurse is on duty.
Outcome Variables: First IV attempt success rate
Predictor Variables: IV technique used, other potential modifiers (age, weight, height, skin shade, indication for IV, history of prematurity and, vein visibility/palpability after tourniquet)
Methods: Subjects who meet inclusion criteria will be randomized to either conventional IV technique or VeinViewer guided technique. The nurse will attempt the IV depending on the randomization. Success or failure on first IV attempt will be recorded. If unsuccessful, other attempts will be tried until a successful IV is placed or the physician decides to give an alternative therapy that does not need IV access.
Statistics: A chi square test will be used to compare the proportion of subjects with successful first attempt IV placement using the VeinViewer technique to that using the conventional method with 95% confidence interval. We, the researchers, will look at the median number of attempts to place an IV in each of the groups. Logistic regression will be performed to test for independent associations. Information collected during the study will also be used for validation of the DIVA score.
Risks: No extra risks are expected above that of receiving a standard IV. The standard risk of bleeding, bruising, pain, and infection will be possible regardless of technique used. The VeinViewer does not expose the patient the ionizing radiation. The use of the VeinViewer technique may increase the time need to place an IV in.
Potential Benefits: With this study, we, the researchers, hope to improve the success rate of children with difficult IV placement in the Emergency Department.
|Condition or disease||Intervention/treatment||Phase|
|Catheterization, Peripheral Phlebotomy||Device: VeinViewer||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||170 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||VeinViewer for Peripheral IV Placement in Children With Difficult IV Access|
|Study Start Date :||October 2006|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
Active Comparator: VeinViewer Arm
Attempts at IV placement will be made with use of the VeinViewer Machine
Using the VeinViewer, IV attempts will be made
No Intervention: Conventional Method
IV attempted with conventional method
- First attempt IV success rates [ Time Frame: Immediately after attempt ]
- Number of attempts required [ Time Frame: Immediately after attempts ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00357799
|United States, Wisconsin|
|Children's Hospital of Wisconsin Emergency Department and Trauma Center|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Kenneth Yen, MD MS||Medical College of WIsconsin and Children's Research Institute|
|Principal Investigator:||Anne Riegert, RN||Children Hospital of Wisconsin Health Systems|
|Principal Investigator:||Marc H Gorelick, MD MSCE||Medical College of Wisconsin and Children's Research Institute|