- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05685290
The Effect of Pushing Technique With Saline on Success of Peripheral Intravenous Catheter Placement
April 5, 2024 updated by: Meltem Gürcan, Akdeniz University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Meltem GÜRCAN, Res. Assist.
- Phone Number: +905556963374 +90506 508 6214
- Email: meltemgurcan32@gmail.com
Study Contact Backup
- Name: Nimet KARATAŞ, Res. Assist.
- Phone Number: +90555 696 3374
- Email: nimetkaratas@akdeniz.edu.tr
Study Locations
-
-
Antalya
-
Konyaaltı, Antalya, Turkey, 07070
- Meltem Gürcan
-
-
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
1 second to 17 years (Child)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- None.
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
Pushing with saline technique
|
Peripheral venous catheter placement by pushing with saline technique
|
Active Comparator: Control group
Traditional method
|
Peripheral venous catheter placement with the traditional method by nurses in the clinic routinely.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Immediately after the procedure.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Sevcan ATAY TURAN, PhD, Assistant Professor
- Study Director: Ayla KAYA, PhD, Research Assistant
- Study Director: Elif GÜLER, PhD, Professor
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)
July 17, 2023
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
January 15, 2024
Study Registration Dates
First Submitted
January 3, 2023
First Submitted That Met QC Criteria
January 13, 2023
First Posted (Actual)
January 17, 2023
Study Record Updates
Last Update Posted (Actual)
April 9, 2024
Last Update Submitted That Met QC Criteria
April 5, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 273
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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