No registrations found.
ID
Source
Health condition
Vessel visualization, Venipuncture, VascuLuminator, Infuus, Venous cannulation, Accuvein, Veinviewer, succes rate
Sponsors and support
Intervention
Outcome measures
Primary outcome
To evaluate the effectivity of three different devices developed to visualize blood vessels with light, in intravenous cannulation in children.
Secondary outcome
To investigate if the devices are able to visualize blood vessels in the study population.
Background summary
In this study, we investigate three devices based on near-infrared light to visualize blood vessels, compared to a control group. Study population consists of children scheduled for elective surgery, obtaining an intravenous cannulation. Main outcome is success rate at first attempt.
Study objective
To evaluate the usefulness of three near-infrared based devices for intravenous cannulation in children prior to surgery.
Study design
Measurements are made by self-report at the moment the procedure is performed. There is no follow-up of patients required.
Intervention
The study consists of four arms: Three arms with one of the devices (the Accuvein, Veinviewer or the VascuLuminator) and one control arm with the standard procedure of intravenous cannulation. When one of the devices is allocated, it will be used during the procedure of intravenous cannulation. The study will be conducted as a pragmatic randomized trial. The operating room is the unit of randomization. Randomization will be performed by blinded envelopes, which will be opened by the investigator (NC) each day at 7.45 AM. The investigator will place the devices in the indicated operating room and provide CRF’s. One operating room will only receive a CRF and perform the procedure without device. Adaptive randomization will be used to guarantee that all three devices and the control group are equally divided among the different surgical specialties.
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, scheduled for elective surgery.
Exclusion criteria
Patients with a canula already in situ.
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 | NL2541 |
| NTR-old | NTR2659 |
| Other | METC UMC Utrecht (amendement) : 09-312/C |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |