Evaluation of a new vessel imaging system to support arterial and venous cannulation in neonates.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26449

Enrollment

360

Registered

2010-06-02

Start date

2010-06-15

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, Infuus, Venous cannulation, neonates

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 peripheral cannulations in neonates at the neonatal intensive care units of the Erasmus MC (Sophia).

Exclusion criteria

Exclusion criteria: None.

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 or arterial cannulation (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. Pain perception by the patient during the puncture will be measured by a standardized pain scales: the COMFORT scale. Other risk factors for difficult punctures, such as skin color, weigth and length, age, history of frequent puncturing and certain medications or diseases, 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. Pain perception by the patient during the puncture will be measured by a standardized pain scales: the COMFORT scale. Other risk factors for difficult punctures, such as skin color, weigth and length, age, history of frequent puncturing and certain medications or diseases, 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)