No registrations found.
ID
Source
Health condition
Infrared, Venous cannulation, Vessel visualization, Venipuncture
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.)
Secondary outcome
1. Number of punctures;
2. Time to successful cannulation, if the procedure succeeded or not and if the VL was helpful or not. Timing 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.
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 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.
Study objective
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.
Study design
Measurements are made by an independend investigator. 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, undergoing elective, non-cardiac surgery in a primary general hospital at Curacao in the Caribbean will be included in the present trial.
Exclusion criteria
N/A
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 | NL2910 |
| NTR-old | NTR3056 |
| Other | METC UMC Utrecht : 09-312/C |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |