Clinical Investigation Acc. to MPG §23b: Open-label Prospective Study Comparing the Handling of the Handling of Two Peripheral IV Catheter (PIV) Systems (Ported and Non Ported) in Randomized Order

B. Braun Melsungen AG2 sites in 1 country2,340 target enrollmentDecember 2014

ConditionsIntravenous Access According to Instructions For Use

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Intravenous Access According to Instructions For Use
Sponsor: B. Braun Melsungen AG
Enrollment: 2340
Locations: 2
Primary Endpoint: Incidence of successful puncturing on the first attempt
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2014

End Date

March 2016

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

B. Braun Melsungen AG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Incidence of successful puncturing on the first attempt

Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours

Secondary Outcomes

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)
Adverse Events(From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours)