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Study Comparing the Handling of Two Peripheral IV Catheter Systems

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B. Braun

Status

Completed

Conditions

Intravenous Access According to Instructions For Use

Treatments

Device: Peripheral IV catheter

Study type

Observational

Funder types

Industry

Identifiers

NCT02213965
HC-O-H 1411

Details and patient eligibility

About

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.

Enrollment

2,340 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

2,340 participants in 2 patient groups

Vasofix® Safety
Description:
Peripheral IV catheter Vasofix® Safety
Treatment:
Device: Peripheral IV catheter
Introcan Safety®
Description:
Peripheral IV catheter Introcan Safety® IV catheter
Treatment:
Device: Peripheral IV catheter

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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