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Supporting intravenous cannulation in children with infrared light; A clinical evaluation of three systems.


- candidate number8801
- NTR NumberNTR2659
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-dec-2010
- Secondary IDs09-312/C  METC UMC Utrecht (amendement)
- Public TitleSupporting intravenous cannulation in children with infrared light; A clinical evaluation of three systems.
- Scientific TitleSupporting intravenous cannulation in children with infrared light; A clinical evaluation of three systems.
- ACRONYM
- hypothesisTo evaluate the usefulness of three near-infrared based devices for intravenous cannulation in children prior to surgery.
- Healt Condition(s) or Problem(s) studiedVenipuncture, VascuLuminator, Infuus, Venous cannulation, Vessel visualization, Accuvein, Veinviewer, Succes rate
- Inclusion criteriaAll consecutive patients aged less than 18 years, scheduled for elective surgery.
- Exclusion criteriaPatients with a canula already in situ.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 12-jan-2011
- planned closingdate12-jul-2011
- Target number of participants1000
- InterventionsThe study consists of four arms: Three arms with one of the devices (the Accuvein, Veinviewer or the VascuLuminator) and one control arm with the standard procedure of intravenous cannulation. When one of the devices is allocated, it will be used during the procedure of intravenous cannulation. The study will be conducted as a pragmatic randomized trial. The operating room is the unit of randomization. Randomization will be performed by blinded envelopes, which will be opened by the investigator (NC) each day at 7.45 AM. The investigator will place the devices in the indicated operating room and provide CRF’s. One operating room will only receive a CRF and perform the procedure without device. Adaptive randomization will be used to guarantee that all three devices and the control group are equally divided among the different surgical specialties.
- Primary outcomeTo evaluate the effectivity of three different devices developed to visualize blood vessels with light, in intravenous cannulation in children.
- Secondary outcomeTo investigate if the devices are able to visualize blood vessels in the study population.
- TimepointsMeasurements are made by self-report 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)
University Medical Center Utrecht (UMCU)
- PublicationsN/A
- Brief summaryIn this study, we investigate three devices based on near-infrared light to visualize blood vessels, compared to a control group. Study population consists of children scheduled for elective surgery, obtaining an intravenous cannulation. Main outcome is success rate at first attempt.
- Main changes (audit trail)
- RECORD20-dec-2010 - 3-jan-2011


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