Study Comparing the Handling of Two Peripheral IV Catheter Systems

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

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.

Study Overview

• Status: Completed
• Conditions: Intravenous Access According to Instructions For Use
• Intervention / Treatment: Device: Peripheral IV catheter

• Study Type: Observational
• Enrollment (Actual): 2340

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
  • Tübingen, Germany
    • Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Adults and children

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vasofix® Safety; Peripheral IV catheter Vasofix® Safety	Device: Peripheral IV catheter; Intravenous access according to Instructions For Use
Introcan Safety®; Peripheral IV catheter Introcan Safety® IV catheter	Device: Peripheral IV catheter; Intravenous access according to Instructions For Use

What is the study measuring?

Primary Outcome Measures

Outcome 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 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

Other Outcome Measures

Outcome Measure	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		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

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Claudia Spies, Univ.- Prof. Dr., Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: August 8, 2014
• First Posted (Estimate): August 12, 2014

Study Record Updates

• Last Update Posted (Actual): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Intravenous Catheter; Vasofix safety; Introcan safety
• Other Study ID Numbers: HC-O-H 1411