Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06312215
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2024-03-08
Brief Title:
Effect Of Open And Closed System Peripheral Catheters Used In Pediatric Services
Sponsor:
Tarsus University
Organization:
Tarsus University
Study Overview
Official Title:
Effect Of Open And Closed System Peripheral Catheters Used In Pediatric Services On Insertion Success Duration Of Stay And Development Of Complications A Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study was conducted as a randomized controlled experimental research to examine the effects of open and closed system peripheral catheters on the success of insertion duration of stay and development of complications in children aged 1-18 years in pediatric services The population of the study consisted of children admitted to the Pediatric Services of the Istanbul Faculty of Medicine and the sample included a total of N80 children who met the sample criteria and underwent catheter insertion between May 2023 and October 2023 The sample was divided into two groups closed system peripheral venous catheter group n40 and open system peripheral venous catheter group n40 The data of the study were collected using a Data Collection Form Peripheral Venous Catheter Monitoring Form Visual Infusion Phlebitis Detection Scale and Pediatric Peripheral Intravenous Infiltration Scale
Detailed Description:
The study was conducted as a randomized controlled experimental research to determine the impact of open and closed system peripheral catheters on the success of insertion duration of stay and the development of complications infiltration phlebitis in children aged 1-18 years
Location and Characteristics of the Study
The research data were collected from pediatric patients in the Department of Pediatric Health and Diseases at Istanbul University Istanbul Faculty of Medicine The pediatric services within the Department include Gastrohepatology Neurology Nutrition and Metabolism Cardiology Allergy and Immunology Nephrology Rheumatology Endocrinology and Chest Diseases comprising a total of 47 service beds
Study Population and Sample
The study population consisted of children admitted to the pediatric services of Istanbul University Istanbul Faculty of Medicine between May 2023 and October 2023 The sample size was determined based on literature findings Boztepe and Abusfia 2015 considering a type I error rate of 005 a test power of 091 α 005 1-β 095 The minimum sample size for each group was calculated as 66 n33 However to mitigate the possibility of losing cases a total sample size of 80 patients was determined with 40 patients in each group Therefore 40 patients would constitute the open system catheter group and 40 patients would form the closed system catheter group The selection of the sample was carried out through simple randomization based on predefined criteria for grouping the children
Randomization
In the study there are two groups the study group using closed system peripheral catheters and the control group receiving the routine procedure of the clinic with open system peripheral catheters Children meeting the inclusion criteria were assigned to groups through a randomization process
Subsequently whenever a child meeting the inclusion criteria presented to the pediatric service a nurse working in the unit other than the researcher asked the child to randomly select a piece of paper from a bag If the paper indicated control group the child was assigned to the control group if it indicated study group the child was assigned to the study group
This randomization method utilizing a simple and practical approach with the use of paper lots from a bag ensures that each eligible child has an equal chance of being assigned to either the control or study group The process helps minimize bias and ensures a more balanced distribution of characteristics across the groups contributing to the reliability of the study results
Data Collection
In the pediatric service where the research was conducted peripheral venous access and care for children were carried out by nurses using an open system catheter The control group in this study consisted of the open system catheter group
Data collection was performed in 6 stages
Stage Before the data collection process a pilot application was conducted with 10 children to assess the suitability of the forms used in the research Final adjustments were made to the forms after the pilot application
Stage Children included in the sample aged 6 and older and their parents were informed about the research and verbal and written consents informed consent were obtained
Stage Patients meeting the sample selection criteria were randomly and equally distributed into two groups using the randomization method 1st group control group with open system peripheral catheter application n40 2nd group study group with closed system peripheral catheter application n40 It was ensured that the parents of children in both groups were present
Stage Before the procedure the researcher filled out the Patient Identification Form for all children in the groups
Stage According to the group to which the child belonged the researcher applied the Peripheral Catheter Insertion and Removal Protocol The protocol included the following steps
Hands were washed and necessary materials gloves cotton an appropriately sized catheter for the child 05 chlorhexidine-containing 70 alcohol transparent drape venous valve saline solution syringe were prepared
The area for catheter insertion was selected upper extremity veins Using aseptic technique the catheter was inserted using the appropriate method gloves were worn the catheter area was wiped three times with a solution of 2 chlorhexidine-containing 70 alcohol and it was allowed to dry the cleaned area was not touched after wiping
After inserting the catheter it was secured using a transparent drape for easy observation
For children with open system peripheral catheters a venous valve was attached after catheter insertion to reduce movement of the catheter
Catheter dressing was changed if there was moisture looseness or noticeable contamination
Stage After the insertion of the peripheral venous catheter PVC children were monitored daily using the Daily Monitoring Form until 48 hours after removal
Data Analysis
The data obtained in the research were analyzed using the Statistical Package for Social Sciences SPSS 220 program Normal distribution analysis was conducted and it was determined that the data did not follow a normal distribution Therefore non-parametric tests were employed for the analyses
For qualitative variables frequency and percentage calculations were performed
For quantitative variables mean standard deviation and median tests were conducted
Categorical variables were compared using the Chi-square test while quantitative variables were compared using the Mann-Whitney U test
A significance level of p005 was considered in the analyses This means that statistically significant differences were considered when the p-value was below 005 This value represents the significance level used to determine differences between various groups in the study
Location and Characteristics of the Study
The research data were collected from pediatric patients in the Department of Pediatric Health and Diseases at Istanbul University Istanbul Faculty of Medicine The pediatric services within the Department include Gastrohepatology Neurology Nutrition and Metabolism Cardiology Allergy and Immunology Nephrology Rheumatology Endocrinology and Chest Diseases comprising a total of 47 service beds
Study Population and Sample
The study population consisted of children admitted to the pediatric services of Istanbul University Istanbul Faculty of Medicine between May 2023 and October 2023 The sample size was determined based on literature findings Boztepe and Abusfia 2015 considering a type I error rate of 005 a test power of 091 α 005 1-β 095 The minimum sample size for each group was calculated as 66 n33 However to mitigate the possibility of losing cases a total sample size of 80 patients was determined with 40 patients in each group Therefore 40 patients would constitute the open system catheter group and 40 patients would form the closed system catheter group The selection of the sample was carried out through simple randomization based on predefined criteria for grouping the children
Randomization
In the study there are two groups the study group using closed system peripheral catheters and the control group receiving the routine procedure of the clinic with open system peripheral catheters Children meeting the inclusion criteria were assigned to groups through a randomization process
Subsequently whenever a child meeting the inclusion criteria presented to the pediatric service a nurse working in the unit other than the researcher asked the child to randomly select a piece of paper from a bag If the paper indicated control group the child was assigned to the control group if it indicated study group the child was assigned to the study group
This randomization method utilizing a simple and practical approach with the use of paper lots from a bag ensures that each eligible child has an equal chance of being assigned to either the control or study group The process helps minimize bias and ensures a more balanced distribution of characteristics across the groups contributing to the reliability of the study results
Data Collection
In the pediatric service where the research was conducted peripheral venous access and care for children were carried out by nurses using an open system catheter The control group in this study consisted of the open system catheter group
Data collection was performed in 6 stages
Stage Before the data collection process a pilot application was conducted with 10 children to assess the suitability of the forms used in the research Final adjustments were made to the forms after the pilot application
Stage Children included in the sample aged 6 and older and their parents were informed about the research and verbal and written consents informed consent were obtained
Stage Patients meeting the sample selection criteria were randomly and equally distributed into two groups using the randomization method 1st group control group with open system peripheral catheter application n40 2nd group study group with closed system peripheral catheter application n40 It was ensured that the parents of children in both groups were present
Stage Before the procedure the researcher filled out the Patient Identification Form for all children in the groups
Stage According to the group to which the child belonged the researcher applied the Peripheral Catheter Insertion and Removal Protocol The protocol included the following steps
Hands were washed and necessary materials gloves cotton an appropriately sized catheter for the child 05 chlorhexidine-containing 70 alcohol transparent drape venous valve saline solution syringe were prepared
The area for catheter insertion was selected upper extremity veins Using aseptic technique the catheter was inserted using the appropriate method gloves were worn the catheter area was wiped three times with a solution of 2 chlorhexidine-containing 70 alcohol and it was allowed to dry the cleaned area was not touched after wiping
After inserting the catheter it was secured using a transparent drape for easy observation
For children with open system peripheral catheters a venous valve was attached after catheter insertion to reduce movement of the catheter
Catheter dressing was changed if there was moisture looseness or noticeable contamination
Stage After the insertion of the peripheral venous catheter PVC children were monitored daily using the Daily Monitoring Form until 48 hours after removal
Data Analysis
The data obtained in the research were analyzed using the Statistical Package for Social Sciences SPSS 220 program Normal distribution analysis was conducted and it was determined that the data did not follow a normal distribution Therefore non-parametric tests were employed for the analyses
For qualitative variables frequency and percentage calculations were performed
For quantitative variables mean standard deviation and median tests were conducted
Categorical variables were compared using the Chi-square test while quantitative variables were compared using the Mann-Whitney U test
A significance level of p005 was considered in the analyses This means that statistically significant differences were considered when the p-value was below 005 This value represents the significance level used to determine differences between various groups in the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None