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


- candidate number7911
- NTR NumberNTR2277
- 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 venous cannulation in children prior to elective, non-cardiac surgery.
- Scientific TitleEvaluation of a new vessel imaging system to support venous cannulation in children prior to elective, non-cardiac surgery.
- ACRONYM
- hypothesisTo evaluate the usefulness of the VascuLuminator in children that are obtaining a venous cannulation prior to elective non-cardiac surgery.
- Healt Condition(s) or Problem(s) studiedVessel visualization, Venipuncture, Venous cannulation, Infrared
- Inclusion criteriaAll consecutive patients aged less than 18 years, undergoing elective, non-cardiac surgery, will be included in the present trial.
- Exclusion criteriaN/A
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2010
- planned closingdate1-okt-2010
- Target number of participants400
- 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 or anesthetic 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.
- Primary outcomeThe main study parameter is the percentage of procedures in which more than one puncture is required for successful venous cannulation (i.e. failure rate).
- Secondary outcome1. Secondary 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;
2. Patient characteristics such as skin color, length and weigth and age, are measured.
- TimepointsMeasurements are made by self-report. 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 prior to elective, non-cardiac surgery, by measuring number of punctures and duration of the procedure. The study takes place in the Netherlands.
- Main changes (audit trail)
- RECORD8-apr-2010 - 15-apr-2010


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