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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON25144

Enrollment

2000

Registered

2010-04-08

Start date

2010-04-26

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vessel visualization, Venipuncture, VascuLuminator, bloedafname, bloedvaten, infrarood

Interventions

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 devi

Eligibility

Inclusion criteria

Inclusion criteria: All consecutive patients aged less than 18 years, referred to the phlebotomy station of a pediatric university hospital for a blood withdrawal.

Exclusion criteria

Exclusion criteria: Blood withdrawals performed by a cappillary puncture instead of a venipuncture.

Design outcomes

Primary

Measure	Time frame
The main study parameter is the percentage of procedures in which more than one puncture is required for successful or venipuncture (i.e. failure rate). A second main parameter is the number of patients in which the VascuLuminator is used during the weeks it is available.	—

Secondary

Measure	Time frame
1. Pain perception by the patient during the puncture will be measured by the FLACC (faces, legs, activity, cry and consolability) scale; 2. Patient characteristics, i.e. skin color and age, are measured to specify in which type of patients the VascuLuminator is mainly used.	—

Contacts

Public ContactNatascha Cuper

Mailstop C.01.230 P.O. Box 85500

n.j.cuper@umcutrecht.nl+31(0)88 755 3243

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)