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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vasofix® Safety | Peripheral IV catheter Vasofix® Safety |
| |
| Introcan Safety® | Peripheral IV catheter Introcan Safety® IV catheter |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral IV catheter | Device | Intravenous access according to Instructions For Use |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Age and gender of the patient | At the beginning of the investigation | |
| ASA score of the patient | At the beginning of the investigation | |
| Weight and height of the patient |
Inclusion:
Exclusion:
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Adults and children
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| Name | Affiliation | Role |
|---|---|---|
| Claudia Spies, Univ.- Prof. Dr. | Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35361115 | Derived | 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. |
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| 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 |
| 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 | Working experience of the user in a hospital in at the beginning of the investigation | At the beginning of the investigation |
| Function of the user | Job title of the user | At the beginning of the investigation |
| Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen | Tübingen | Germany |