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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Daily Monitoring Form
Study Overview
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 N=80 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 (n=40) and open system peripheral venous catheter group (n=40). 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 0.05, a test power of 0.91 (α= 0.05, 1-β= 0.95). The minimum sample size for each group was calculated as 66 (n=33). 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 1 Month to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •• Being between 1 and 18 years of age,
- •Having a catheter requirement for at least 72 hours,
- •The catheter being inserted in the admitting service,
- •Catheters not being inserted under emergency conditions,
- •Absence of other catheters (central venous, arterial, PICC line, etc.),
- •Body temperature not exceeding 38°C,
- •Absence of skin issues in the catheter area,
- •Not undergoing chemotherapy treatment,
- •The catheter being inserted in the upper extremity,
- •Willingness to voluntarily participate in the study.
Exclusion Criteria
- •Being under 1 year of age or over 18 years,
- •Having a catheter requirement of less than 72 hours,
- •Peripheral catheters being inserted under emergency conditions,
- •Presence of other catheters in the child (central venous, arterial, PICC line, etc.),
- •Body temperature exceeding 38°C,
- •Presence of skin issues in the area where the catheter will be inserted,
- •Undergoing chemotherapy treatment,
- •Unwillingness to voluntarily participate in the study.
Arms & Interventions
Closed System Peripheral Catheters
After the area where the catheter would be inserted was cleaned with an antiseptic solution and allowed to dry, a closed-system catheter was applied. Closed-system catheters are devices that allow access through needleless mechanisms, protecting the patient from accidental needle puncture injuries. They have mechanisms preventing blood leakage or pathogen entry.
Intervention: Closed-system catheter (Other)
Control
After the area where the catheter would be inserted was cleaned with an antiseptic solution and allowed to dry, a catheter was applied.
Outcomes
Primary Outcomes
Daily Monitoring Form
Time Frame: 1 day
his form, comprised of 8 questions, has been designed to monitor patients on a daily basis, covering aspects such as catheter day, fluids administered, phlebitis score, infiltration score, skin characteristics, and signs of infection. Nurses used the Daily Monitoring Form to observe and record patient conditions on a daily basis.
Visual Infusion Phlebitis Assessment Scale, Staging Key - Peripheral IV'sVIPAS
Time Frame: 1 day
Developed by Alyce Schultze and Paulette Gallant, this scale was published by the Infusion Nurses Society in 2011 for the purpose of grading phlebitis. The scale involves observing the possible risks of the catheter during the administration of treatment through a peripheral intravenous catheter. It also includes grading the symptoms of phlebitis at each stage if phlebitis develops. The content validity index value of the scale was found to be 0.97
Pediatric peripheral intravenous infiltration assessment tool
Time Frame: 1 day
Pediatric peripheral intravenous infiltration assessment tool: Developed by Simona and evaluated for its psychometric properties, the Pediatric Peripheral Intravenous Infiltration Scale has undergone Turkish validity and reliability assessments by Temizsoy et al. (2017) and is suitable for use in newborns. Cohen kappa value of the scale was 0.80 (p\<0.001) and Pearson correlation coefficient was r=0.95 (p\<0.001). The Cronbach's alpha coefficient of the scale is 0.966, which shows that the level of infitration increases as the stages increase in the evaluation made in five stages.
Patient Identification Form
Time Frame: 1 day
he Patient Identification Form has been prepared by reviewing relevant literature. It consists of 27 questions, encompassing patient-specific information and catheter characteristics.
Secondary Outcomes
No secondary outcomes reported
Investigators
Duygu Sonmez Duzkaya
Principal Investigator
Tarsus University