Status:
COMPLETED
Study Comparing the Handling of Two Peripheral IV Catheter Systems
Lead Sponsor:
B. Braun Melsungen AG
Conditions:
Intravenous Access According to Instructions For Use
Eligibility:
All Genders
Brief Summary
A peripheral intravenous catheter is the most commonly used vascular access device in medicine. Primary objective is to compare insertion and handling of two peripheral intravenous catheters in clinic...
Eligibility Criteria
Inclusion
- Inclusion:
- Patients of the center Anesthesiology, Operating-Room Management and Intensive Care Medicine, Gynaecology and Paediatrics in need for peripheral intravenous access
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
2340 Patients enrolled
Trial Details
Trial ID
NCT02213965
Start Date
December 1 2014
End Date
March 1 2016
Last Update
January 23 2019
Active Locations (2)
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1
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
Berlin, Germany, 13353
2
Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen
Tübingen, Germany