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Evaluation of a new vessel imaging system to support venous cannulation in children prior to elective, non-cardiac surgery in patients with a dark skin color.


- candidate number10312
- NTR NumberNTR3056
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-sep-2011
- Secondary IDs09-312/C METC UMC Utrecht
- Public TitleEvaluation of a new vessel imaging system to support venous cannulation in children prior to elective, non-cardiac surgery in patients with a dark skin color.
- Scientific TitleEvaluation of a new vessel imaging system to support venous cannulation in children prior to elective, non-cardiac surgery in patients with a dark skin color.
- ACRONYM
- hypothesisTo evaluate the usefulness of the VascuLuminator in children with a dark skin color that are obtaining a venous cannulation prior to elective non-cardiac surgery.
- Healt Condition(s) or Problem(s) studiedVenipuncture, Venous cannulation, Infrared, Vessel visualization
- Inclusion criteriaAll consecutive patients aged less than 18 years, undergoing elective, non-cardiac surgery in a primary general hospital at Curacao in the Caribbean will be included in the present trial.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2011
- planned closingdate1-jan-2012
- Target number of participants110
- 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 success at first attempt (defined as the percentage of procedures in which the venous cannulation succeeded at the first attempt. An attempt is a penetration with a needle through the skin.)
- Secondary outcome1. Number of punctures;
2. Time to successful cannulation, if the procedure succeeded or not and if the VL was helpful or not. Timing 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.
- TimepointsMeasurements are made by an independend investigator. There is no follow-up of patients required.
- Trial web siteN/A
- statusopen: patient inclusion
- 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)
University Medical Center Utrecht (UMCU)
- 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 prior to elective, non-cardiac surgery, by measuring number of punctures and duration of the procedure. The study takes place in a primary general hospital at Curacao in the Caribbean.
- Main changes (audit trail)
- RECORD5-sep-2011 - 18-sep-2011


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