Evaluation of a Touchless Vein Scanner for Venepuncture and Cannulation in Pediatric Patients (VENSCAN)
| Tracking Information | |||||
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| First Received Date ICMJE | July 29, 2011 | ||||
| Last Updated Date | September 14, 2011 | ||||
| Start Date ICMJE | January 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
time until completion of procedure [ Time Frame: Day 1 ] [ Designated as safety issue: No ] minutes until successful puncture and cannulation of peripheral vein |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01434537 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
number of attempts until completion of procedure [ Time Frame: Day 1 ] [ Designated as safety issue: No ] number of attempts until successful puncture and cannulation of peripheral vein |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of a Touchless Vein Scanner for Venepuncture and Cannulation in Pediatric Patients | ||||
| Official Title ICMJE | Venepuncture and Vein Cannulation With Support of the AccuVein AV300 Vein Scanner in Paediatric Patients in a Pre-operation Setting | ||||
| Brief Summary | Evaluation of the AccuVein ® AV 300 vein scanner in clinical routine in a pediatric operation room setting for a 4 weeks period. Assessment of usability, anonymous clinical register of every venepuncture(age, gender, size, weight, punction site, number of attempts, time until successful cannulation, local anaesthesia, general anaesthesia, pain scales: faces pain scale und BPS/BPOS). |
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| Detailed Description | For application of drugs and liquids a peripheral venous access is necessary in anaesthesiological procedures.The peripheral venepuncture is a painful procedure and induces a higher level of perioperative stress in children. The punction of peripheral veins in children can be made difficult by the often distinctive amount of subcutaneous fat or other medical conditions. The AccuVein ® AV300 vein scanner is a contactless, laser-driven device made for facilitate the search for peripheral veins up to a depth of 7mm. This could lead to a minimization of time until successful puncture and smaller number of failures. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All patients from 0 to 17 years in a peripoerative setting in the pediatric operation room with need for peripheral venous access. |
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| Condition ICMJE | Venepuncture | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 238 | ||||
| Completion Date | July 2011 | ||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | up to 17 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01434537 | ||||
| Other Study ID Numbers ICMJE | VENSCAN | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Claudia Spies, Charite University, Berlin, Germany | ||||
| Study Sponsor ICMJE | Charite University, Berlin, Germany | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Charite University, Berlin, Germany | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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