Evaluation of a new vessel imaging system to support venipuncture in children.

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 and usability of this system as an aid in venipuncture in children referred to the phlebotomy station of a pediatric hospital. The study takes place in the Netherlands.

To evaluate the usefulness of the VascuLuminator for venipuncture for blood withdrawal in children and to find out for which type of patients the VascuLuminator is mainly used.

Measurements are made by the laboratory nurses themselves after the procedure is performed. There is no follow-up of patients required.

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 laboratory nurse 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.

The study is a pragmatic randomized trial with the week as unit of randomization, which implies that the VascuLuminator is available to use during a certain week or not, depending on randomization outcome. If it is available, the nurse can freely decide to use it or not on a patient. Results from patients of this group are compared to the control group, which consists of patients attending the phlebotomy station in the weeks the VascuLuminator is not available.