Study Comparing the Handling of Two Peripheral IV Catheter Systems

Completed

• Conditions: Intravenous Access According to Instructions For Use
• Interventions: Device: Peripheral IV catheter

• Registration Number: NCT02213965
• Lead Sponsor: B. Braun Melsungen AG

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 clinical routine.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-08-08
• Study First Posted: 2014-08-12
• Study Start: 2014-12
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-21
• Last Update Posted: 2019-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Introcan Safety®	Peripheral IV catheter	Peripheral IV catheter Introcan Safety® IV catheter
Vasofix® Safety	Peripheral IV catheter	Peripheral IV catheter Vasofix® Safety

Primary Outcome Measures

Name	Time	Method
Incidence of successful puncturing on the first attempt	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours

Secondary Outcome Measures

Name	Time	Method
Rate of insertion failures	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
For Vasofix Safety: Rate and nature of use of application port	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Rate and number of recannulation	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Incidence of needle stick injuries	During catheter fixation
Rate of adherence to standard application requirements of catheter placement	During catheter fixation until directly after catheter fixation
General judgment of catheter (school class grading)	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Rate of difficulties to insert catheter and to withdraw the needle with regard to:Penetration characteristics of the needle, insertion and movement of catheter	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Rate and number of testing of ease of moving	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Rate, number and kind/extend of blood emission	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Condition of fixation after completion of catheter insertion	During catheter fixation until directly after catheter insertion	dry and clean, moisturized, soiled?
Adverse Events	From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours

Trial Locations

Locations (2)

Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen; 🇩🇪 Tübingen, Germany