Catheter ComplicationsnexivaNCT05769452
Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications
A study testing closed IV catheter system (BD Nexiva™) and open IV catheter (BD Insyte™ Autoguard™) in people with Catheter Complications and Catheter Leakage, run by Gülçin Özalp Gerçeker at 1 site in Turkey (Türkiye).
Trial summary
Peripheral intravenous catheters (PIVCs) can be used frequently in pediatric hematology oncology patients. There are different types of PIVCs as open and closed. There are studies on adults using the closed IV catheter system, which is a type of PICK. Read more about this study
- Who is it for?
- Ages 1 year to 12 years
- Conditions the study is for
- Catheter Complications, Catheter Leakage
- What is being tested?
- closed IV catheter system (BD Nexiva™) and open IV catheter (BD Insyte™ Autoguard™)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Nov 2022
- Phase
- Interventional
- 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 1 year to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age range of pediatric patients is between 1-12
- Obtaining an informed consent form from the child patient and parent
- Child patient receiving intravenous therapy
Who cannot join
- port or central venous catheter in the pediatric patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications in Pediatric Hematology and Oncology Patients
Peripheral intravenous catheters (PIVCs) can be used frequently in pediatric hematology oncology patients. There are different types of PIVCs as open and closed. There are studies on adults using the closed IV catheter system, which is a type of PICK. However, no study was found in the literature in which the closed IV catheter system was used in the pediatric population.
Read the detailed description
The primary purpose of this research is; to evaluate the effect of two different catheter systems (closed IV catheter system: BD Nexiva™/ peripheral open IV catheter: BD Insyte™ Autoguard™) on catheter stay in pediatric hematology and oncology patients aged 1-12 years.
The secondary aim of the research is; to evaluate the effect of two different catheter systems on the success of catheter placement and the development of complications in the first attempt in pediatric hematology and oncology patients.
- Conditions
- Catheter Complications, Catheter Leakage
- Being tested
- closed IV catheter system (BD Nexiva™), open IV catheter (BD Insyte™ Autoguard™)
- Keywords
- closed IV catheter system, pediatric hematology oncology, first IV attempt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed IV catheter system (BD Nexiva™)Device
Also called BD Nexiva™
There is a high-pressure extension set and a Q-syte split septum needle-free intervention device at the tip of the catheter. It creates a closed integrated system with this apparatus, reducing the risk of catheter-related bloodstream infection.
open IV catheter (BD Insyte™ Autoguard™)Device
Also called BD Insyte™ Autoguard™
BD Instaflash™ needle technology improves initial entry success by confirming vascular access through the needle noch. It has flexible wings for secure cannula fixation.
| Study group | Role | What they receive |
|---|---|---|
| BD Nexiva™ | Experimental | The intervention group was given a closed IV catheter system called BD Nexiva™. Receives: Device: closed IV catheter system (BD Nexiva™) |
| BD Insyte™ Autoguard™ | Experimental | The control group received an open IV catheter called BD Insyte™ Autoguard™. Receives: Device: open IV catheter (BD Insyte™ Autoguard™) |
What is being measured
The primary outcome is the main question the study is designed to answer.
catheter indwelling time
time between catheter insertion and removal
Measured: during the catheterization
success of catheter placement
first IV attempt
Measured: at catheter insertion
Secondary outcomes (1)
development of catheter complications
infiltration
Measured: during the catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2023
- Study start1 Apr 2022
- Primary completion15 Nov 2022
- Study completion30 Nov 2022
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 Catheter ComplicationsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In this study, the intervention group was given a closed IV catheter system called BD Nexiva™; the control group received an open IV catheter called BD Insyte™ Autoguard™. Within the scope of the study, "Peripheral IV Catheter Care Bundle Approach" was applied to all patients.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gülçin Özalp Gerçeker
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
- Investigators
- Nur Olgun, MD, Principal investigator, Dokuz Eylul UniversityHale Ören, MD, Principal investigator, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05769452
- Sponsor's protocol ID
- DEU PHO nexiva
- Acronym
- nexiva
- Status last verified
- Mar 2023
- First submitted
- 3 Mar 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Ozalp Gerceker G, Yildirim BG, Onal A, Oren H, Olgun HN, Bektas M. The effect of the closed intravenous catheter system on first insertion success, indwelling time, and complications in pediatric hematology and oncology patients: A randomized controlled study. Eur J Oncol Nurs. 2023 Dec;67:102430. doi: 10.1016/j.ejon.2023.102430. Epub 2023 Oct 7.
PubMed 37879193
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Closed Intravenous Catheter System on Catheter Success, Length of Stay and Complications in Pediatric Hematology and Oncology Patients
- ClinicalTrials.gov ID
- NCT05769452
- Acronym / sponsor ID
- nexiva / DEU PHO nexiva
- Conditions
- Catheter Complications, Catheter Leakage
- Keywords
- closed IV catheter system, pediatric hematology oncology, first IV attempt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Gülçin Özalp GerçekerUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 15 Mar 2023 (actual)
- 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.
Peripheral intravenous catheters (PIVCs) can be used frequently in pediatric hematology oncology patients. There are different types of PIVCs as open and closed. There are studies on adults using the closed IV catheter system, which is a type of PICK. However, no study was found in the literature in which the closed IV catheter system was used in the pediatric population.
Detailed description
The primary purpose of this research is; to evaluate the effect of two different catheter systems (closed IV catheter system: BD Nexiva™/ peripheral open IV catheter: BD Insyte™ Autoguard™) on catheter stay in pediatric hematology and oncology patients aged 1-12 years.
The secondary aim of the research is; to evaluate the effect of two different catheter systems on the success of catheter placement and the development of complications in the first attempt in pediatric hematology and oncology patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- In this study, the intervention group was given a closed IV catheter system called BD Nexiva™; the control group received an open IV catheter called BD Insyte™ Autoguard™. Within the scope of the study, "Peripheral IV Catheter Care Bundle Approach" was applied to all patients.
| Arm | Type | Receives |
|---|---|---|
| BD Nexiva™ | Experimental | Device: closed IV catheter system (BD Nexiva™)The intervention group was given a closed IV catheter system called BD Nexiva™. |
| BD Insyte™ Autoguard™ | Experimental | Device: open IV catheter (BD Insyte™ Autoguard™)The control group received an open IV catheter called BD Insyte™ Autoguard™. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age range of pediatric patients is between 1-12
- Obtaining an informed consent form from the child patient and parent
- Child patient receiving intravenous therapy
Key exclusion criteria (1 listed)
- port or central venous catheter in the pediatric patient
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 |
|---|---|---|
| closed IV catheter system (BD Nexiva™)Also: BD Nexiva™There is a high-pressure extension set and a Q-syte split septum needle-free intervention device at the tip of the catheter. It creates a closed integrated system with this apparatus, reducing the risk of catheter-related bloodstream infection. | Device | BD Nexiva™ |
| open IV catheter (BD Insyte™ Autoguard™)Also: BD Insyte™ Autoguard™BD Instaflash™ needle technology improves initial entry success by confirming vascular access through the needle noch. It has flexible wings for secure cannula fixation. | Device | BD Insyte™ Autoguard™ |
Primary outcome
catheter indwelling time
Time frame: during the catheterization
time between catheter insertion and removal
success of catheter placement
Time frame: at catheter insertion
first IV attempt
1 secondary outcome
development of catheter complications
Time frame: during the catheterization
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 15 Mar 2023.
- Derived from this study: PubMed 37879193Ozalp Gerceker G, Yildirim BG, Onal A, Oren H, Olgun HN, Bektas M. The effect of the closed intravenous catheter system on first insertion success, indwelling time, and complications in pediatric hematology and oncology patients: A randomized controlled study. Eur J Oncol Nurs. 2023 Dec;67:102430. doi: 10.1016/j.ejon.2023.102430. Epub 2023 Oct 7.
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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.
Nur Olgun, MD principal investigator
Dokuz Eylul University
Hale Ören, MD principal investigator
Dokuz Eylul University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing closed IV catheter system (BD Nexiva™) and open IV catheter (BD Insyte™ Autoguard™) in people with Catheter Complications and Catheter Leakage, run by Gülçin Özalp Gerçeker at 1 site in Turkey (Türkiye).
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 1 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 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
catheter indwelling time (time frame: during the catheterization). The study lists 2 primary outcomes in all. 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 NCT05769452, 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 15 Mar 2023.