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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03277092
Other study ID # RC 22/17
Secondary ID
Status Completed
Phase N/A
First received September 7, 2017
Last updated November 29, 2017
Start date October 2, 2017
Est. completion date November 28, 2017

Study information

Verified date June 2017
Source IRCCS Burlo Garofolo
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Reaching a peripheral venous access or making a blood sample in a scared infant or toddler can be challenging even for experienced nurses o pediatricians. Up to 60% of children report pain and distress during venipuncture and multiple attempts can result in more difficult physical and emotional conditions for subsequent insertions so that the procedure should be performed with the less number of punctures as possible. In about one third of children, more than one attempt is required to achieve peripheral intravenous cannulation. In the last years, specific tools have been developed to enhance the success in venipuncture or incannulation. Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site. According to previous studies, NIR had shown a trend in reduction of time employed for a blood sample, in children younger of 6 yr.

The aim of this trial is to investigate if the use of the VeinViewer® in a pediatric blood drawing center could decrease time spent to perform the procedure and improve the rate of first attempt success.


Recruitment information / eligibility

Status Completed
Enrollment 115
Est. completion date November 28, 2017
Est. primary completion date November 28, 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Inclusion Criteria:

- subjects accessing the outpatient blood-drawing service

Exclusion Criteria:

- application of topical anaesthetic cream

Study Design


Related Conditions & MeSH terms


Intervention

Device:
VeinViewer®
Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site
Procedure:
Usual care
The blood drawing is performed traditionally

Locations

Country Name City State
Italy IRCCS Burlo Garofolo Trieste

Sponsors (1)

Lead Sponsor Collaborator
IRCCS Burlo Garofolo

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to perform the procedure In seconds, from the placement of the tourniquet until the blood flows in the needle Intraprocedural
Secondary Success at first attempt Percentage of success at first attempt Intraprocedural