Clinical trial NCT02213965: Study Comparing the Handling of Two Peripheral IV Catheter Systems
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intravenous Access According to Instructions For Use
Keywords: Intravenous Catheter
Vasofix safety
Introcan safety
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2014-08-12
Enrollment: 2340
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults and children

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.


Eligibility 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

Primary outcomes:
measure: Incidence of successful puncturing on the first attempt
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Secondary outcomes:
measure: Rate of insertion failures
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate of difficulties to insert catheter and to withdraw the needle with regard to:Penetration characteristics of the needle, insertion and movement of catheter
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate and number of testing of ease of moving
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate and number of recannulation
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Rate, number and kind/extend of blood emission
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Incidence of needle stick injuries
timeFrame: During catheter fixation
measure: Condition of fixation after completion of catheter insertion
timeFrame: During catheter fixation until directly after catheter insertion
measure: Rate of adherence to standard application requirements of catheter placement
timeFrame: During catheter fixation until directly after catheter fixation
measure: For Vasofix Safety: Rate and nature of use of application port
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: General judgment of catheter (school class grading)
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Adverse Events
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Other outcomes:
measure: Age and gender of the patient
timeFrame: At the beginning of the investigation
measure: ASA score of the patient
timeFrame: At the beginning of the investigation
measure: Weight and height of the patient
timeFrame: At the beginning of the investigation
measure: Vein and skin condition of the patient
timeFrame: At the beginning of the investigation
measure: Location of Peripheral Intervenous Catheter
timeFrame: After catheter fixation
measure: Judgment on application port and wings given by user
timeFrame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
measure: Working experience of the user
timeFrame: At the beginning of the investigation
measure: Function of the user
timeFrame: At the beginning of the investigation
Locations:
city: Berlin
country: Germany
facility: Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
city: Tübingen
country: Germany
facility: Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen
Study officials:
affiliation: Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
name: Claudia Spies, Univ.- Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgeli R, Schmidt K, Neumann T, Kruppa J, Fohring U, Hofmann P, Rosenberger P, Falk E, Boemke W, Spies C. A comparison of first-attempt cannulation success of peripheral venous catheter systems with and without wings and injection ports in surgical patients-a randomized trial. BMC Anesthesiol. 2022 Mar 31;22(1):88. doi: 10.1186/s12871-022-01631-7.