Child, OnlyNCT06312215
Effect Of Open And Closed System Peripheral Catheters Used In Pediatric Services
A study testing Closed-system catheter in people with Child, Only and Catheter Infection, run by Tarsus University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only, Catheter Infection, Catheter Complications
- What is being tested?
- Closed-system catheter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 May 2023to 2 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- • 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,
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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.
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 (n=40), 2nd group: study group with closed system peripheral catheter application (n=40)). 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, 0.5% 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) 22.0 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 p<0.05 was considered in the analyses. This means that statistically significant differences were considered when the p-value was below 0.05. This value represents the significance level used to determine differences between various groups in the study.
- Conditions
- Child, Only, Catheter Infection, Catheter Complications
- Being tested
- Closed-system catheter
- Keywords
- Closed System Peripheral Catheter, Peripheral Catheter, child
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed-system catheterOther
Closed-system catheters was applied
| Study group | Role | What they receive |
|---|---|---|
| Closed System Peripheral Catheters | Experimental | 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. Receives: Other: Closed-system catheter |
| Control | No intervention | After the area where the catheter would be inserted was cleaned with an antiseptic solution and allowed to dry, a catheter was applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Identification Form
he Patient Identification Form has been prepared by reviewing relevant literature. It consists of 27 questions, encompassing patient-specific information and catheter characteristics.
Measured: 1 day
Daily Monitoring Form
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.
Measured: 1 day
Visual Infusion Phlebitis Assessment Scale, Staging Key - Peripheral IV'sVIPAS
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
Measured: 1 day
Pediatric peripheral intravenous infiltration assessment tool
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start26 May 2023
- Primary completion2 Oct 2023
- Study completion2 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Child, OnlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Duygu Sonmez Duzkaya, Tarsus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312215
- Sponsor's protocol ID
- 1763831
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Amjad I, Murphy T, Nylander-Housholder L, Ranft A. A new approach to management of intravenous infiltration in pediatric patients: pathophysiology, classification, and treatment. J Infus Nurs. 2011 Jul-Aug;34(4):242-9. doi: 10.1097/NAN.0b013e31821da1b3.
PubMed 21734520Clark E, Giambra BK, Hingl J, Doellman D, Tofani B, Johnson N. Reducing risk of harm from extravasation: a 3-tiered evidence-based list of pediatric peripheral intravenous infusates. J Infus Nurs. 2013 Jan-Feb;36(1):37-45. doi: 10.1097/NAN.0b013e3182798844.
PubMed 23271150Corley A, Ullman AJ, Mihala G, Ray-Barruel G, Alexandrou E, Rickard CM. Peripheral intravenous catheter dressing and securement practice is associated with site complications and suboptimal dressing integrity: A secondary analysis of 40,637 catheters. Int J Nurs Stud. 2019 Dec;100:103409. doi: 10.1016/j.ijnurstu.2019.103409. Epub 2019 Aug 28.
PubMed 31629208Doellman D, Hadaway L, Bowe-Geddes LA, Franklin M, LeDonne J, Papke-O'Donnell L, Pettit J, Schulmeister L, Stranz M. Infiltration and extravasation: update on prevention and management. J Infus Nurs. 2009 Jul-Aug;32(4):203-11. doi: 10.1097/NAN.0b013e3181aac042.
PubMed 19605999Duncan M, Warden P, Bernatchez SF, Morse D, (2018), A bundled approach to decrease the rate of primary bloodstream infections related to peripheral intravenous catheters, J Assoc Vasc Access, 23(1), 15-22.
Arias-Fernandez L, Suerez-Mier B, Martinez-Ortega MD, Lana A. Incidence and risk factors of phlebitis associated to peripheral intravenous catheters. Enferm Clin. 2017 Mar-Apr;27(2):79-86. doi: 10.1016/j.enfcli.2016.07.008. Epub 2016 Sep 16. English, Spanish.
PubMed 27640931Gonzalez Lopez JL, Arribi Vilela A, Fernandez del Palacio E, Olivares Corral J, Benedicto Marti C, Herrera Portal P. Indwell times, complications and costs of open vs closed safety peripheral intravenous catheters: a randomized study. J Hosp Infect. 2014 Feb;86(2):117-26. doi: 10.1016/j.jhin.2013.10.008. Epub 2013 Dec 1.
PubMed 24373830Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
PubMed 33394637
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06312215
- Acronym / sponsor ID
- 1763831
- Conditions
- Child, Only, Catheter Infection, Catheter Complications
- Keywords
- Closed System Peripheral Catheter, Peripheral Catheter, child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Tarsus UniversityUniversity, hospital or other
- Study start
- 26 May 2023 (actual)
- Primary completion
- 2 Oct 2023 (actual)
- Study completion
- 2 Oct 2023 (actual)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (n=40), 2nd group: study group with closed system peripheral catheter application (n=40)). 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, 0.5% 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) 22.0 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 p<0.05 was considered in the analyses. This means that statistically significant differences were considered when the p-value was below 0.05. This value represents the significance level used to determine differences between various groups in the study.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Closed System Peripheral Catheters | Experimental | Other: Closed-system catheterAfter 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. |
| Control | No intervention | –After the area where the catheter would be inserted was cleaned with an antiseptic solution and allowed to dry, a catheter was applied. |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- • Being between 1 and 18 years of age,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Closed-system catheterClosed-system catheters was applied | Other | Closed System Peripheral Catheters |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Background: PubMed 21734520Amjad I, Murphy T, Nylander-Housholder L, Ranft A. A new approach to management of intravenous infiltration in pediatric patients: pathophysiology, classification, and treatment. J Infus Nurs. 2011 Jul-Aug;34(4):242-9. doi: 10.1097/NAN.0b013e31821da1b3.
- Background: PubMed 23271150Clark E, Giambra BK, Hingl J, Doellman D, Tofani B, Johnson N. Reducing risk of harm from extravasation: a 3-tiered evidence-based list of pediatric peripheral intravenous infusates. J Infus Nurs. 2013 Jan-Feb;36(1):37-45. doi: 10.1097/NAN.0b013e3182798844.
- Background: PubMed 31629208Corley A, Ullman AJ, Mihala G, Ray-Barruel G, Alexandrou E, Rickard CM. Peripheral intravenous catheter dressing and securement practice is associated with site complications and suboptimal dressing integrity: A secondary analysis of 40,637 catheters. Int J Nurs Stud. 2019 Dec;100:103409. doi: 10.1016/j.ijnurstu.2019.103409. Epub 2019 Aug 28.
- Background: PubMed 19605999Doellman D, Hadaway L, Bowe-Geddes LA, Franklin M, LeDonne J, Papke-O'Donnell L, Pettit J, Schulmeister L, Stranz M. Infiltration and extravasation: update on prevention and management. J Infus Nurs. 2009 Jul-Aug;32(4):203-11. doi: 10.1097/NAN.0b013e3181aac042.
- BackgroundDuncan M, Warden P, Bernatchez SF, Morse D, (2018), A bundled approach to decrease the rate of primary bloodstream infections related to peripheral intravenous catheters, J Assoc Vasc Access, 23(1), 15-22.
- Background: PubMed 27640931Arias-Fernandez L, Suerez-Mier B, Martinez-Ortega MD, Lana A. Incidence and risk factors of phlebitis associated to peripheral intravenous catheters. Enferm Clin. 2017 Mar-Apr;27(2):79-86. doi: 10.1016/j.enfcli.2016.07.008. Epub 2016 Sep 16. English, Spanish.
- Background: PubMed 24373830Gonzalez Lopez JL, Arribi Vilela A, Fernandez del Palacio E, Olivares Corral J, Benedicto Marti C, Herrera Portal P. Indwell times, complications and costs of open vs closed safety peripheral intravenous catheters: a randomized study. J Hosp Infect. 2014 Feb;86(2):117-26. doi: 10.1016/j.jhin.2013.10.008. Epub 2013 Dec 1.
- Background: PubMed 33394637Gorski LA, Hadaway L, Hagle ME, Broadhurst D, Clare S, Kleidon T, Meyer BM, Nickel B, Rowley S, Sharpe E, Alexander M. Infusion Therapy Standards of Practice, 8th Edition. J Infus Nurs. 2021 Jan-Feb 01;44(1S Suppl 1):S1-S224. doi: 10.1097/NAN.0000000000000396. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed-system catheter in people with Child, Only and Catheter Infection, run by Tarsus University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Identification Form (time frame: 1 day). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312215, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.