Evaluation of Introcan Safety 3 Closed IV Catheter

August 2, 2023 updated by: B. Braun Melsungen AG
Incidence and time of occurrence of blood leakage with the closed intravascular catheter Introcan Safety 3 in comparison to Introcan Safety

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dorsten, Germany
        • KKRN Katholisches Klinikum Ruhrgebiet Nord GmbH (KKRN)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients in need for intravenous access

Description

Inclusion Criteria:

  • need for intravenous access

Exclusion Criteria:

  • n. a.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Introcan Safety 3
Closed IV Catheter
Introcan Safety
IV catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Frequency and time of occurence of blood leakage
Time Frame: Within one minute
Within one minute

Secondary Outcome Measures

Outcome Measure
Time Frame
Problems during catheter insertion and fixation of Introcan Safety 3
Time Frame: During insertion and fixation of catheter
During insertion and fixation of catheter
Necessity of disconnection of catheter
Time Frame: During catheter placement
During catheter placement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gertrud Haeseler, Prof., KKRN

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 21, 2014

First Posted (Estimated)

July 22, 2014

Study Record Updates

Last Update Posted (Actual)

August 3, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • HC-O-H-1207

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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