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Evaluation of a new vessel imaging system to support venipuncture in children.


- candidate number7909
- NTR NumberNTR2276
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-apr-2010
- Secondary IDs09-312/C  METC UMC Utrecht
- Public TitleEvaluation of a new vessel imaging system to support venipuncture in children.
- Scientific TitleEvaluation of a new vessel imaging system to support venipuncture in children.
- ACRONYM
- hypothesisTo evaluate the usefulness of the VascuLuminator for venipuncture for blood withdrawal in children and to find out for which type of patients the VascuLuminator is mainly used.
- Healt Condition(s) or Problem(s) studiedVessel visualization, Blood withdrawal, Infrared
- Inclusion criteriaAll consecutive patients aged less than 18 years, referred to the phlebotomy station of a pediatric university hospital for a blood withdrawal.
- Exclusion criteriaBlood withdrawals performed by a cappillary puncture instead of a venipuncture.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 26-apr-2010
- planned closingdate26-aug-2010
- Target number of participants2000
- InterventionsThe VascuLuminator is the investigational product in this study. It is able to non-invasively visualize blood vessels by means of near-infrared light.
The intervention consists of the use of the device by the laboratory nurse during the puncture. There will be no extra intervention on the patient, since the patient already is obtaining a puncture as part of their normal treatment.
The study is a pragmatic randomized trial with the week as unit of randomization, which implies that the VascuLuminator is available to use during a certain week or not, depending on randomization outcome. If it is available, the nurse can freely decide to use it or not on a patient. Results from patients of this group are compared to the control group, which consists of patients attending the phlebotomy station in the weeks the VascuLuminator is not available.
- Primary outcomeThe main study parameter is the percentage of procedures in which more than one puncture is required for successful or venipuncture (i.e. failure rate). A second main parameter is the number of patients in which the VascuLuminator is used during the weeks it is available.
- Secondary outcome1. Pain perception by the patient during the puncture will be measured by the FLACC (faces, legs, activity, cry and consolability) scale;
2. Patient characteristics, i.e. skin color and age, are measured to specify in which type of patients the VascuLuminator is mainly used.
- TimepointsMeasurements are made by the laboratory nurses themselves after the procedure is performed. There is no follow-up of patients required.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD student Natascha Cuper
- CONTACT for SCIENTIFIC QUERIES Jurgen Graaff, de
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryA system (the VascuLuminator) was developed by our department of Medical Technology and Clinical Physics, that is able to visualize vessels underneath the skin. In this study, we test the effectivity and usability of this system as an aid in venipuncture in children referred to the phlebotomy station of a pediatric hospital. The study takes place in the Netherlands.
- Main changes (audit trail)
- RECORD8-apr-2010 - 15-sep-2011


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