Study Comparing the Handling of Two Peripheral IV Catheter Systems
NCT ID: NCT02213965
Last Updated: 2019-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2340 participants
OBSERVATIONAL
2014-12-31
2016-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Vasofix® Safety
Peripheral IV catheter Vasofix® Safety
Peripheral IV catheter
Intravenous access according to Instructions For Use
Introcan Safety®
Peripheral IV catheter Introcan Safety® IV catheter
Peripheral IV catheter
Intravenous access according to Instructions For Use
Interventions
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Peripheral IV catheter
Intravenous access according to Instructions For Use
Eligibility Criteria
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Inclusion Criteria
* Male and female patients, adult and paediatric
* Is able to give written informed consent, for children the legal representatives
Exclusion:
* Participation in another intervention trial during the study
* Lacking willingness to save and hand out data within the study
* Accommodation in an institution due to an official or judicial order
* The potential insertion site shows deformities, phlebitis, infiltration, dermatitis, burns, lesions, nerve injuries with paresthesia or tattoos
* Study PIV catheter site will be placed below an old infusion site
* Patient has a documented or known allergy sensitivity to a medical adhesive product such as transparent film, adhesive dressing, tapes or liquid skin protectants
* Patient requires the application of a topical ointment, or solution under the dressing in addition to the prep required in the protocol
* Patient has or had previous IV catheter-related phlebitis or infiltration during this hospitalization
* Patients with fear of injection
* Preterm infants
ALL
No
Sponsors
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B. Braun Melsungen AG
INDUSTRY
Responsible Party
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Principal Investigators
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Claudia Spies, Univ.- Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
Locations
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Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen
Tübingen, , Germany
Countries
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References
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Morgeli R, Schmidt K, Neumann T, Kruppa J, Fohring U, Hofmann P, Rosenberger P, Falk E, Boemke W, Spies C. A comparison of first-attempt cannulation success of peripheral venous catheter systems with and without wings and injection ports in surgical patients-a randomized trial. BMC Anesthesiol. 2022 Mar 31;22(1):88. doi: 10.1186/s12871-022-01631-7.
Other Identifiers
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HC-O-H 1411
Identifier Type: -
Identifier Source: org_study_id
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