Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579820
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
Effect of Tubular Bandage Application on Peripheral Intravenous Catheter Usage Time and Infiltration in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of Tubular Bandage Application on Peripheral Intravenous Catheter Usage Time and Infiltration in Children
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
chıldren
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 eg 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
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 eg 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 IV 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
Parentchilds proficiency in Turkish
Intact skin integrity in the application area
First-time application of the peripheral venous catheter to the middle part of the childs forearm
Recommendation by a physician for intravenous fluid containing 5 dextrose 045 NaCl sodium chloride and 75 KCLpotassium chloride through a peripheral venous catheter
Childs 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 375C
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
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
Parentchilds proficiency in Turkish
Intact skin integrity in the application area
First-time application of the peripheral venous catheter to the middle part of the childs forearm
Recommendation by a physician for intravenous fluid containing 5 dextrose 045 NaCl sodium chloride and 75 KCLpotassium chloride through a peripheral venous catheter
Childs 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 375C
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None