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Completed

NCT Number: NCT02213965

Study Comparing the Handling of Two Peripheral IV Catheter Systems

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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Key information

Conditions

Intravenous Access According to Instructions For Use

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin, Berlin, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peripheral IV catheter

Device

Intravenous access according to Instructions For Use

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

B. Braun Melsungen AG

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 12, 2014
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.