Effect of Tubular Bandage Application on Peripheral Intravenous Catheter Usage Time and Infiltration in Children
- Conditions
- Child, Only
- Interventions
- Combination Product: tubular bandage
- Registration Number
- NCT06579820
- Lead Sponsor
- Istanbul University
- Brief Summary
In pediatric patients, placement of peripheral intravenous catheters is the most commonly performed invasive medical procedure. In addition to the administration of medications, parenteral nutrition, intravenous fluids, and blood products, peripheral intravenous catheters are placed prophylactically before procedures and for emergency use in unstable patients.
One of the most common complications of peripheral intravenous catheters is infiltration. Infiltration is a vascular trauma resulting from a lesion in the vascular layers and subsequent perforation, resulting in the leakage of medications or non-vesicant solutions into the tissues surrounding the site of placement of the peripheral venous catheter.
In pediatric patients, physical factors (e.g. hyperactivity, sweating), tight fixation (may affect blood circulation and iatrogenic skin injury), loose fixation (may cause peripheral intravenous catheter displacement and infection), poor-quality fixation (may cause unplanned removal and skin injuries due to pressure), etc. causes more peripheral intravenous catheter fixation problems in pediatric patients than in adult patients Additional fixation products may be effective in preventing dislocation and micromotion in an active pediatric patient. However, limited recommendations regarding medical adhesive tapes and additional fixation products are guided only by low-evidence studies. The purpose of this study was to determine the effect of tubular bandage use on the duration of pediatric peripheral intravenous catheter use and the incidence of infiltration.
- Detailed Description
RESEARCH OBJECTIVES AND DESIGN The study was conducted as a randomized controlled experimental design to determine the effect of tubular bandage application on the duration of peripheral venous catheter use and the frequency of infiltration in children aged 6-12 years who were receiving intravenous (I.V.) fluids through a peripheral venous catheter in the pediatric infection ward. RESEARCH HYPOTHESES Hypothesis 0 (H0): There is no significant effect of tubular bandage application on the duration of peripheral venous catheter use and the frequency of infiltration in children.
Hypothesis 1 (H1): The duration of peripheral venous catheter use is longer in children who receive tubular bandage application compared to those who do not. Hypothesis 2 (H2): The frequency of infiltration is lower in children who receive tubular bandage application compared to those who do not. RESEARCH VARIABLES The dependent variables of the study are the duration of peripheral venous catheter use and the frequency of infiltration occurrence. The independent variable is defined as tubular bandage application. RESEARCH POPULATION AND SAMPLE For this experimental study, the sample size was calculated as 100 participants in total (50 for each group) based on a power analysis derived from a similar study conducted by Atıcı et al. in 2019 with 49 patients. The randomization was done using the urn method, which is equivalent to full randomization. In the urn method, two parameters (α and β) are discussed, represented by two different colored balls: red and white. α can be either white or red, and β represents the ball of the opposite color to α. One ball is randomly selected, and if the selected ball is white, the individual is assigned to the α group, while if it is red, they are assigned to the β group. This process is repeated for each assignment. In the study, the red color was assigned to the experimental group, and the white color was assigned to the control group. When a child met the sampling criteria, these pre-prepared balls were placed in a black bag, and any nurse on duty was asked to select a ball with closed eyes. Based on the color of the selected ball, the child was assigned to either the control or experimental group, ensuring random distribution of participants into two groups. Sample Selection Criteria
* Willingness to participate in the study
* Parent/child's proficiency in Turkish
* Intact skin integrity in the application area
* First-time application of the peripheral venous catheter to the middle part of the child's forearm
* Recommendation by a physician for intravenous fluid containing 5% dextrose, 0.45% NaCl (sodium chloride), and 75% KCL(potassium chloride) through a peripheral venous catheter
* Child's age between 6-12 years
* Successful placement of the peripheral venous catheter on the first attempt
Sample Exclusion Criteria
* Coagulation abnormalities
* Receiving blood and blood products through the peripheral venous catheter
* Nutritional issues
* Hematologic or oncologic diseases
* Congenital genetic or neurological disorders
* Problems with skin integrity and movement in the upper extremities
* Sensitivity to the tubular bandage
* Fever above 37.5°C
* Accidental dislodgement of the catheter
* Early completion of treatment and removal of the catheter DATA COLLECTION FORMS AND TOOLS
The data collection process utilized the following:
* Data Collection Form
* Pediatric Peripheral Infusion Scale
The auxiliary tools used in data collection include:
* Tubular Bandage
* Transparent Adhesive Cove
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description experimental group tubular bandage The experimental group consisted of the group to which a tubular bandage was placed over the routinely applied peripheral intravenous catheters.
- Primary Outcome Measures
Name Time Method pediatric peripheral infiltration scale, information collection form about a year The effect of tubular bandage on infiltration and catheter use time in children will be analyzed.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Istanbul University
🇹🇷Istanbul, Fatih, Turkey
Istanbul Unıversity
🇹🇷Istanbul, Turkey