Intravenous Access According to Instructions For Use
Conditions
Keywords
Intravenous Catheter, Vasofix safety, Introcan safety
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.
Interventions
DEVICEPeripheral IV catheter
Intravenous access according to Instructions For Use
Sponsors
B. Braun Melsungen AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | During catheter fixation until directly after catheter insertion | dry and clean, moisturized, soiled? |
| 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 | — |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Weight and height of the patient | At the beginning of the investigation | — |
| Vein and skin condition of the patient | At the beginning of the investigation | — |
| Location of Peripheral Intervenous Catheter | After catheter fixation | — |
| Judgment on application port and wings given by user | From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours | — |
| Working experience of the user | At the beginning of the investigation | Working experience of the user in a hospital in at the beginning of the investigation |
| Function of the user | At the beginning of the investigation | Job title of the user |
| Age and gender of the patient | At the beginning of the investigation | — |
| ASA score of the patient | At the beginning of the investigation | — |
Countries
Germany
Outcome results
None listed