To evaluate the usefulness of the VascuLuminator for venous cannulation in children.
ID
Bron
Verkorte titel
Aandoening
venous cannulation, venipuncture, near-infrared, vessel visualization, VascuLuminator.
Veneuze cannulatie, infuus, venapunctie, infrarood licht, vaat imaging, VascuLuminator
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study parameter is the percentage of procedures in which more than one puncture is required for successful venous cannulation or venipuncture (i.e. failure rate).
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 that are difficult to puncture, by measuring number of punctures and duration of the procedure. The study takes place in the Netherlands.
Doel van het onderzoek
To evaluate the usefulness of the VascuLuminator for venous cannulation in children.
Onderzoeksopzet
Measurements are made by the nurses of the postoperative care unit at the moment the procedure is performed.
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, referred to the pediatric anesthesiologist for venipuncuture or intravenous cannulation, will be included in the present trial.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
If a patient needs two cannulas placed at the same moment, the second puncture will be excluded (since the best place is already occupied with the first cannula).
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1791 |
| NTR-old | NTR1901 |
| Ander register | METC UMC Utrecht : 09-312/C |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |