Nurse's RoleNCT05685290
The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement
A study testing Pushing with saline technique and Traditional method in people with Nurse's Role, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this project is to determine the effect of pushing with saline technique on the success of peripheral IV catheter placement in a pediatric hematology and oncology sample. This research is a randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 1 day to 17 years
- Conditions the study is for
- Nurse's Role
- What is being tested?
- Pushing with saline technique and Traditional method
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2023to 15 Jan 2024
- 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 day to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The child who ages of 0-17.
- The child's need for peripheral IV catheter placement for treatment.
- A score of 4 or higher on the Difficult Intravenous Access Score for Children
Who cannot join
- None.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement: A Randomized Controlled Study in a Pediatric Hematology and Oncology Sample
The aim of this project is to determine the effect of pushing with saline technique on the success of peripheral IV catheter placement in a pediatric hematology and oncology sample. This research is a randomized controlled experimental study.
Read the detailed description
The sample of the study consists of children who aged 0-17. It is planned to collect the research data in Akdeniz University Hospital Pediatric Hematology and Oncology Outpatient Clinic. Data Collection Tools are 'Personal Information Form for Children', 'Catheterization Description Form' and 'The Difficult Intravenous Access (DIVA) Score for children '. DIVA Score will be used pre-intervention to determine whether patients have a difficult vein. Children with DIVA score of 4 and above will be randomly assigned to the intervention and control groups. The attempt to place an IV catheter in children in the intervention group will be carried out by "pushing with saline" (SF) technique. In this way, it is predicted that the success of IV intervention in difficult vascular access will increase and the number of attempts will decrease significantly. Peripheral catheter placement in the control group will be performed with the traditional method routinely implemented by nurses.
- Conditions
- Nurse's Role
- Being tested
- Pushing with saline technique, Traditional method
- Keywords
- Pediatric oncology, Intravenous Catheter Placement, nursing, randomized controlled study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pushing with saline techniqueOther
Peripheral venous catheter placement by pushing with saline technique
Traditional methodOther
Peripheral venous catheter placement with the traditional method by nurses in the clinic routinely.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Pushing with saline technique Receives: Other: Pushing with saline technique |
| Control group | Active comparator | Traditional method Receives: Other: Traditional method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheterization Description Form
The form contains the catheter information regarding the children. It includes 7 questions including the time elapsed since the last vascular access, causes of catheter removal complications (infiltration, vascular damage, etc.), IV catheter location, IV catheter size (number), and peripheral vein where the catheter was placed. Primary endpoint of the study is Catheterization Description Form.
Measured: Immediately after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2023
- Study start17 Jul 2023
- Primary completion30 Nov 2023
- Study completion15 Jan 2024
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 Nurse's RoleStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Gürcan, Akdeniz University
- Investigators
- Sevcan ATAY TURAN, PhD, Study director, Assistant ProfessorAyla KAYA, PhD, Study director, Research AssistantElif GÜLER, PhD, Study director, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05685290
- Sponsor's protocol ID
- 273
- Status last verified
- Apr 2024
- First submitted
- 3 Jan 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2.
PubMed 39002409
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement: A Randomized Controlled Study in a Pediatric Hematology and Oncology Sample
- ClinicalTrials.gov ID
- NCT05685290
- Acronym / sponsor ID
- 273
- Conditions
- Nurse's Role
- Keywords
- Pediatric oncology, Intravenous Catheter Placement, nursing, randomized controlled study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 17 Jul 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 17 Jan 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.
The aim of this project is to determine the effect of pushing with saline technique on the success of peripheral IV catheter placement in a pediatric hematology and oncology sample. This research is a randomized controlled experimental study.
Detailed description
The sample of the study consists of children who aged 0-17. It is planned to collect the research data in Akdeniz University Hospital Pediatric Hematology and Oncology Outpatient Clinic. Data Collection Tools are 'Personal Information Form for Children', 'Catheterization Description Form' and 'The Difficult Intravenous Access (DIVA) Score for children '. DIVA Score will be used pre-intervention to determine whether patients have a difficult vein. Children with DIVA score of 4 and above will be randomly assigned to the intervention and control groups. The attempt to place an IV catheter in children in the intervention group will be carried out by "pushing with saline" (SF) technique. In this way, it is predicted that the success of IV intervention in difficult vascular access will increase and the number of attempts will decrease significantly. Peripheral catheter placement in the control group will be performed with the traditional method routinely implemented by nurses.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Pushing with saline techniquePushing with saline technique |
| Control group | Active comparator | Other: Traditional methodTraditional method |
Who may qualify
- Ages
- 1 day to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The child who ages of 0-17.
- The child's need for peripheral IV catheter placement for treatment.
- A score of 4 or higher on the Difficult Intravenous Access Score for Children
Key exclusion criteria (1 listed)
- None.
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 |
|---|---|---|
| Pushing with saline techniquePeripheral venous catheter placement by pushing with saline technique | Other | Intervention group |
| Traditional methodPeripheral venous catheter placement with the traditional method by nurses in the clinic routinely. | Other | Control group |
Primary outcome
Catheterization Description Form
Time frame: Immediately after the procedure.
The form contains the catheter information regarding the children. It includes 7 questions including the time elapsed since the last vascular access, causes of catheter removal complications (infiltration, vascular damage, etc.), IV catheter location, IV catheter size (number), and peripheral vein where the catheter was placed. Primary endpoint of the study is Catheterization Description Form.
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 9 Apr 2024.
- Derived from this study: PubMed 39002409Gurcan M, Karatas N, Kaya A, Turan SA, Guler E. The effect of a pushing technique with normal saline on peripheral intravenous catheter placement success in paediatric haematology and oncology: A randomized controlled trial. Eur J Oncol Nurs. 2024 Aug;71:102656. doi: 10.1016/j.ejon.2024.102656. Epub 2024 Jul 2.
- Individual participant dataSharing planned: No
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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.
Sevcan ATAY TURAN, PhD study director
Assistant Professor
Ayla KAYA, PhD study director
Research Assistant
Elif GÜLER, PhD study director
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pushing with saline technique and Traditional method in people with Nurse's Role, run by Akdeniz University 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 9 Apr 2024. 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?
Catheterization Description Form (time frame: Immediately after the procedure.). 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 NCT05685290, 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 9 Apr 2024.