Study Comparing the Handling of Two Peripheral IV Catheter Systems

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Intravenous Access According to Instructions For Use

Intervention / Treatment
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* Device: Peripheral IV catheter


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vasofix® Safety<br>Peripheral IV catheter Vasofix® Safety | Device: Peripheral IV catheter<br>* Intravenous access according to Instructions For Use<br>|
| Introcan Safety®<br>Peripheral IV catheter Introcan Safety® IV catheter | Device: Peripheral IV catheter<br>* Intravenous access according to Instructions For Use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of insertion failures |  | 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 and number of recannulation |  | 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 | 
| Incidence of needle stick injuries |  | During catheter fixation | 
| Condition of fixation after completion of catheter insertion | dry and clean, moisturized, soiled? | During catheter fixation until directly after catheter insertion | 
| Rate of adherence to standard application requirements of catheter placement |  | During catheter fixation until directly after catheter fixation | 
| 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 | 
| General judgment of catheter (school class grading) |  | From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours | 
| Adverse Events |  | From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Introcan safety, Intravenous Catheter, Vasofix safety