To 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.
ID
Bron
Aandoening
Infrared, Venous cannulation, Vessel visualization, Venipuncture
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The 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.)
Achtergrond van het onderzoek
A 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.
Doel van het onderzoek
To 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.
Onderzoeksopzet
Measurements are made by an independend investigator. There is no follow-up of patients required.
Onderzoeksproduct en/of interventie
The 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.
Publiek
P.O. Box 85500
Natascha Cuper
Utrecht 3508 GA
The Netherlands
+31(0)88 755 3243
n.j.cuper@umcutrecht.nl
Wetenschappelijk
P.O. Box 85500
Natascha Cuper
Utrecht 3508 GA
The Netherlands
+31(0)88 755 3243
n.j.cuper@umcutrecht.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
All 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
N/A
Opzet
Deelname
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In overige registers
Register | ID |
---|---|
NTR-new | NL2910 |
NTR-old | NTR3056 |
Ander register | METC UMC Utrecht : 09-312/C |
ISRCTN | ISRCTN wordt niet meer aangevraagd. |