No registrations found.
ID
Source
Brief title
Health condition
venous cannulation, venipuncture, near-infrared, vessel visualization, VascuLuminator.
Veneuze cannulatie, infuus, venapunctie, infrarood licht, vaat imaging, VascuLuminator
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
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, or blood is collected in the tube (in case of a venipuncture).
Pain perception by the patient during the puncture will be measured by standardized pain scales; for patients less than 4 years the FLACC (faces, legs, activity, cry and consolability) scale, for patients between 4 and 7 years the Wong – Baker Faces scale, and for children above 7 years of age the VAS (Visual Analogue Scale).
Other risk factors for difficult punctures, such as skin color, weigth and length, age, history of frequent puncturing and certain medications or diseases (corticosteroids, chemotherapy, down syndrome, history of frequent puncturing), will be registered.
Background summary
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.
Study objective
To evaluate the usefulness of the VascuLuminator for venous cannulation in children.
Study design
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.
Intervention
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.
P.O. Box 85500
Natascha Cuper
Utrecht 3508 GA
The Netherlands
+31(0)88 755 3243
n.j.cuper@umcutrecht.nl
P.O. Box 85500
Natascha Cuper
Utrecht 3508 GA
The Netherlands
+31(0)88 755 3243
n.j.cuper@umcutrecht.nl
Inclusion criteria
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.
Exclusion criteria
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).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL1791 |
| NTR-old | NTR1901 |
| Other | METC UMC Utrecht : 09-312/C |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |