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Study Comparing the Handling of Two Peripheral IV Catheter Systems

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ClinicalTrials.gov Identifier: NCT02213965
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
B. Braun Melsungen AG

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.

Condition or disease Intervention/treatment
Intravenous Access According to Instructions For Use Device: Peripheral IV catheter

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Study Type : Observational
Actual Enrollment : 2340 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : December 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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




Primary Outcome Measures :
  1. Incidence of successful puncturing on the first attempt [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]

Secondary Outcome Measures :
  1. Rate of insertion failures [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]
  2. Rate of difficulties to insert catheter and to withdraw the needle with regard to:Penetration characteristics of the needle, insertion and movement of catheter [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]
  3. Rate and number of testing of ease of moving [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]
  4. Rate and number of recannulation [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]
  5. Rate, number and kind/extend of blood emission [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]
  6. Incidence of needle stick injuries [ Time Frame: During catheter fixation ]
  7. Condition of fixation after completion of catheter insertion [ Time Frame: During catheter fixation until directly after catheter insertion ]
    dry and clean, moisturized, soiled?

  8. Rate of adherence to standard application requirements of catheter placement [ Time Frame: During catheter fixation until directly after catheter fixation ]
  9. For Vasofix Safety: Rate and nature of use of application port [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]
  10. General judgment of catheter (school class grading) [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]
  11. Adverse Events [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]

Other Outcome Measures:
  1. Age and gender of the patient [ Time Frame: At the beginning of the investigation ]
  2. ASA score of the patient [ Time Frame: At the beginning of the investigation ]
  3. Weight and height of the patient [ Time Frame: At the beginning of the investigation ]
  4. Vein and skin condition of the patient [ Time Frame: At the beginning of the investigation ]
  5. Location of Peripheral Intervenous Catheter [ Time Frame: After catheter fixation ]
  6. Judgment on application port and wings given by user [ Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours ]
  7. Working experience of the user [ Time Frame: At the beginning of the investigation ]
    Working experience of the user in a hospital in at the beginning of the investigation

  8. Function of the user [ Time Frame: At the beginning of the investigation ]
    Job title of the user



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adults and children
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02213965


Locations
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Germany
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
Berlin, Germany, 13353
Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen
Tübingen, Germany
Sponsors and Collaborators
B. Braun Melsungen AG
Investigators
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Principal Investigator: Claudia Spies, Univ.- Prof. Dr. Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin

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Responsible Party: B. Braun Melsungen AG
ClinicalTrials.gov Identifier: NCT02213965     History of Changes
Other Study ID Numbers: HC-O-H 1411
First Posted: August 12, 2014    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Keywords provided by B. Braun Melsungen AG:
Intravenous Catheter
Vasofix safety
Introcan safety