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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR2277 |
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Date of registration:
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08/04/2010 |
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Primary sponsor: |
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Public title:
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Evaluation of a new vessel imaging system to support venous cannulation in children prior to elective, non-cardiac surgery.
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Scientific title:
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Evaluation of a new vessel imaging system to support venous cannulation in children prior to elective, non-cardiac surgery. -
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Date of first enrolment:
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1/5/2010 |
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Target sample size:
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400 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2277 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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Natascha
Cuper |
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Address:
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Mailstop C.01.230
P.O. Box 85500
3508 GA
Utrecht
The Netherlands |
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Telephone:
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+31(0)88 755 3243 |
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Email:
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n.j.cuper@umcutrecht.nl |
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Affiliation:
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Name:
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Jurgen
Graaff, de |
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Address:
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Mailstop Q.04.2.313
P.O. Box 85500
3508 GA
Utrecht
The Netherlands |
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Telephone:
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+31(0)88 755 59619 |
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Email:
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j.c.degraaff-2@umcutrecht.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All consecutive patients aged less than 18 years, undergoing elective, non-cardiac surgery, will be included in the present trial.
Exclusion criteria: N/A
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Vessel visualization, Venipuncture, Venous cannulation, Infrared
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Intervention(s)
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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 device by the pediatric anesthetist or anesthetic nurse during the puncture. There will be no extra intervention on the patient, since the patient already is obtaining a puncture as part of their normal treatment.
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Primary Outcome(s)
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The main study parameter is the percentage of procedures in which more than one puncture is required for successful venous cannulation (i.e. failure rate).
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Secondary Outcome(s)
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1. 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;
2. Patient characteristics such as skin color, length and weigth and age, are measured.
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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