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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27154

Enrollment

200

Registered

2009-07-08

Start date

2009-10-01

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

venous cannulation, venipuncture, near-infrared, vessel visualization, VascuLuminator. Veneuze cannulatie, infuus, venapunctie, infrarood licht, vaat imaging, VascuLuminator

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 pediatric anesthesiologist for venipuncuture or intravenous cannulation, will be included in the present trial.

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

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)