Study Comparing the Handling of Two Peripheral IV Catheter Systems

January 21, 2019 updated by: B. Braun Melsungen AG

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2340

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

  • Germany
      • Berlin, Germany, 13353
        • Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
      • Tübingen, Germany
        • Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults and children

Description

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

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of insertion failures
Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
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
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
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
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Rate and number of recannulation
Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
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
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Incidence of needle stick injuries
Time Frame: During catheter fixation
During catheter fixation
Condition of fixation after completion of catheter insertion
Time Frame: During catheter fixation until directly after catheter insertion
dry and clean, moisturized, soiled?
During catheter fixation until directly after catheter insertion
Rate of adherence to standard application requirements of catheter placement
Time Frame: During catheter fixation until directly after catheter fixation
During catheter fixation until directly after catheter fixation
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
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
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
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Adverse Events
Time Frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Age and gender of the patient
Time Frame: At the beginning of the investigation
At the beginning of the investigation
ASA score of the patient
Time Frame: At the beginning of the investigation
At the beginning of the investigation
Weight and height of the patient
Time Frame: At the beginning of the investigation
At the beginning of the investigation
Vein and skin condition of the patient
Time Frame: At the beginning of the investigation
At the beginning of the investigation
Location of Peripheral Intervenous Catheter
Time Frame: After catheter fixation
After catheter fixation
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
From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
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
At the beginning of the investigation
Function of the user
Time Frame: At the beginning of the investigation
Job title of the user
At the beginning of the investigation

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
B. Braun Melsungen AG

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudia Spies, Univ.- Prof. Dr., Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 12, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HC-O-H 1411

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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