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Evaluation of a new vessel imaging system to support arterial and venous cannulation in neonates.


- candidate number8110
- NTR NumberNTR2351
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jun-2010
- Secondary IDs80-82305-98-09030 / 11-024 ZonMW / MEC UMCU
- Public TitleEvaluation of a new vessel imaging system to support arterial and venous cannulation in neonates.
- Scientific TitleEvaluation of a new vessel imaging system to support arterial and venous cannulation in neonates.
- ACRONYM
- hypothesisTo evaluate the usefulness of the VascuLuminator for arterial and venous cannulation in neonates.
- Healt Condition(s) or Problem(s) studiedNeonates, Venipuncture, Infuus, Venous cannulation, Vessel visualization
- Inclusion criteriaAll consecutive peripheral cannulations in neonates at the neonatal intensive care units of the Erasmus MC (Sophia).
- Exclusion criteriaNone.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 15-jun-2010
- planned closingdate15-sep-2010
- Target number of participants360
- 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 staff of the neonatal intensive care unit 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 or arterial cannulation (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.
Pain perception by the patient during the puncture will be measured by a standardized pain scales: the COMFORT scale.
Other risk factors for difficult punctures, such as skin color, weigth and length, age, history of frequent puncturing and certain medications or diseases, will be registered.
- TimepointsMeasurements are made by the staff of the neonatal intensive 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 arterial and venous cannulation in neonates, by measuring number of punctures and duration of the procedure. The measurements take place at the Erasmus MC (Sophia) in the Netherlands, while the UMC Utrecht is the performer of the study.
- Main changes (audit trail)
- RECORD2-jun-2010 - 28-apr-2011


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