Intravenous Access According to Instructions For UseNCT02213965
Study Comparing the Handling of Two Peripheral IV Catheter Systems
An observational study of Intravenous Access According to Instructions For Use, run by B. Braun Melsungen AG at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Intravenous Access According to Instructions For Use
- What is being tested?
- Peripheral IV catheter
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 2,340 participants
- Where
- 2 sitesGermany
- Study dates
- Dec 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adults and children
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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 locations and contacts
2 sites in 1 country.
Germany2 sites
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
Berlin, 13353
Universitätsklinik für Anästhesiologie und Intensivmedizin Tübingen
Tübingen
About this study
Official 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
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.
- Being tested
- Peripheral IV catheter
- Keywords
- Intravenous Catheter, Vasofix safety, Introcan safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral IV catheterDevice
Intravenous access according to Instructions For Use
| Study group | Role | What they receive |
|---|---|---|
| Vasofix® Safety | Peripheral IV catheter Vasofix® Safety Receives: Device: Peripheral IV catheter | |
| Introcan Safety® | Peripheral IV catheter Introcan Safety® IV catheter Receives: Device: Peripheral IV catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of successful puncturing on the first attempt
Measured: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Secondary outcomes (11)
Rate of insertion failures
Measured: 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
Measured: 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
Measured: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Rate and number of recannulation
Measured: 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
Measured: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Incidence of needle stick injuries
Measured: During catheter fixation
Condition of fixation after completion of catheter insertion
dry and clean, moisturized, soiled?
Measured: During catheter fixation until directly after catheter insertion
Rate of adherence to standard application requirements of catheter placement
Measured: During catheter fixation until directly after catheter fixation
For Vasofix Safety: Rate and nature of use of application port
Measured: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
General judgment of catheter (school class grading)
Measured: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Adverse Events
Measured: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startDec 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intravenous Access According to Instructions For UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- B. Braun Melsungen AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Claudia Spies, Univ.- Prof. Dr., Principal investigator, Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02213965
- Sponsor's protocol ID
- HC-O-H 1411
- Status last verified
- Jan 2019
- First submitted
- 22 Jul 2014
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 35361115
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02213965
- Acronym / sponsor ID
- HC-O-H 1411
- Keywords
- Intravenous Catheter, Vasofix safety, Introcan safety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,340 participants (actual)
- Lead sponsor
- B. Braun Melsungen AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 12 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vasofix® Safety | – | Device: Peripheral IV catheterPeripheral IV catheter Vasofix® Safety |
| Introcan Safety® | – | Device: Peripheral IV catheterPeripheral IV catheter Introcan Safety® IV catheter |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adults and children
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral IV catheterIntravenous access according to Instructions For Use | Device | Introcan Safety®, Vasofix® Safety |
Primary outcome
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
11 secondary outcomes
Rate of insertion failures
Time frame: 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
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
Rate and number of recannulation
Time frame: 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
Incidence of needle stick injuries
Time frame: During catheter fixation
Condition of fixation after completion of catheter insertion
Time frame: 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
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
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
Adverse Events
Time frame: From catheter fixation until the stay in operation theatre and/or recovery room up to 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Derived from this study: PubMed 35361115Morgeli 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, Univ.- Prof. Dr. principal investigator
Klinik für Anästhesiologie mit Schwerpunkt operative Intensivmedizin CVK/CCM, Charité-Universitätsmedizin Berlin
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intravenous Access According to Instructions For Use, run by B. Braun Melsungen AG at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02213965, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.