Study Comparing the Handling of Two Peripheral IV Catheter Systems

NCT ID: NCT02213965

Last Updated: 2019-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2340 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Intravenous Access According to Instructions For Use

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Vasofix® Safety

Peripheral IV catheter Vasofix® Safety

Peripheral IV catheter

Intervention Type DEVICE

Intravenous access according to Instructions For Use

Introcan Safety®

Peripheral IV catheter Introcan Safety® IV catheter

Peripheral IV catheter

Intervention Type DEVICE

Intravenous access according to Instructions For Use

Interventions

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Peripheral IV catheter

Intravenous access according to Instructions For Use

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B. Braun Melsungen AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Claudia Spies, Univ.- Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Berlin, , Germany

Site Status

Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen

Tübingen, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 35361115 (View on PubMed)

Other Identifiers

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HC-O-H 1411

Identifier Type: -

Identifier Source: org_study_id

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