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


- candidate number6071
- NTR NumberNTR1901
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jul-2009
- Secondary IDs09-312/C METC UMC Utrecht
- Public TitleEvaluation of a new vessel imaging system to support venous cannulation in children.
- Scientific TitleEvaluation of a new vessel imaging system to support venous cannulation in children.
- ACRONYMN/A
- hypothesisTo evaluate the usefulness of the VascuLuminator for venous cannulation in children.
- Healt Condition(s) or Problem(s) studiedVessel visualization, Venipuncture, VascuLuminator, Infuus, Venous cannulation
- Inclusion criteriaAll consecutive patients aged less than 18 years, referred to the pediatric anesthesiologist for venipuncuture or intravenous cannulation, will be included in the present trial.
- Exclusion criteriaIf a patient needs two cannulas placed at the same moment, the second puncture will be excluded (since the best place is already occupied with the first cannula).
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2009
- planned closingdate1-okt-2010
- Target number of participants200
- 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 pediatric anesthetist 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.
- Primary outcomeThe main study parameter is the percentage of procedures in which more than one puncture is required for successful venous cannulation or venipuncture (i.e. failure rate).
- Secondary outcomeSecondary parameters will be the number of punctures and the duration of the procedure. The duration of the procedure starts at the moment the first attempt is made to search for a suitable vessel, by palpating or looking (with the system in use, looking with the system) and ends at the moment the line is flushed, or blood is collected in the tube (in case of a venipuncture).
Pain perception by the patient during the puncture will be measured by standardized pain scales; for patients less than 4 years the FLACC (faces, legs, activity, cry and consolability) scale, for patients between 4 and 7 years the Wong Baker Faces scale, and for children above 7 years of age the VAS (Visual Analogue Scale).
Other risk factors for difficult punctures, such as skin color, weigth and length, age, history of frequent puncturing and certain medications or diseases (corticosteroids, chemotherapy, down syndrome, history of frequent puncturing), will be registered.
- TimepointsMeasurements are made by the nurses of the postoperative care unit at the moment 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 of this system as an aid in venous cannulation in children that are difficult to puncture, by measuring number of punctures and duration of the procedure. The study takes place in the Netherlands.
- Main changes (audit trail)
- RECORD8-jul-2009 - 10-okt-2009


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