Effect of Tubular Bandage Application on Peripheral Intravenous Catheter Usage Time and Infiltration in Children (chıldren)

August 28, 2024 updated by: DİLEK SÖNMEZ SAĞLIK, Istanbul University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

100

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

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Istanbul Unıversity
    • Fatih
      • Istanbul, Fatih, Turkey
        • Recruiting
        • Istanbul University
        • Contact:
          • dilek sönmez sağlık

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

  • Child

Accepts Healthy Volunteers

Yes

Description

inclusion 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, and 75% KCL through a peripheral venous catheter
  • Child's age between 6-12 years
  • Successful placement of the peripheral venous catheter on the first attempt

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: experimental group
The experimental group consisted of the group to which a tubular bandage was placed over the routinely applied peripheral intravenous catheters.
Combination product: tubular bandage
The experimental group consisted of the group in which a tubular bandage was applied over the PIC, which was routinely applied.
No Intervention: control group
The routine practice used for the application of peripheral intravenous catheters in the ward constituted the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pediatric peripheral infiltration scale, information collection form
Time Frame: about a year
The effect of tubular bandage on infiltration and catheter use time in children will be analyzed.
about a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Investigators

  • Principal Investigator: dilek sönmez sağlık, dilek.sonmez@istanbul.edu.tr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 10, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

August 27, 2024

First Submitted That Met QC Criteria

August 28, 2024

First Posted (Actual)

August 30, 2024

Study Record Updates

Last Update Posted (Actual)

August 30, 2024

Last Update Submitted That Met QC Criteria

August 28, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DSONMEZSAGLIK

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Individual Participant Data Set
    Information comments: pubmed

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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