Child, OnlychıldrenNCT06579820
Effect of Tubular Bandage Application on Peripheral Intravenous Catheter Usage Time and Infiltration in Children
A study testing tubular bandage in people with Child, Only, run by Istanbul University at 2 sites in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Child, Only
- What is being tested?
- tubular bandage
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 10 Feb 2024to 30 Dec 2024
- 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 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Sensitivity to the tubular bandage
- Fever above 37.5°C
- Accidental dislodgement of the catheter
- Early completion of treatment and removal of the catheter
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Istanbul University
Istanbul, Fatih
dilek sönmez sağlık
- Recruiting
Istanbul Unıversity
Istanbul
About this study
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.
Read the 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
- Conditions
- Child, Only
- Being tested
- tubular bandage
- Keywords
- child, infiltration,catheter usage time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tubular bandageCombination product
The experimental group consisted of the group in which a tubular bandage was applied over the PIC, which was routinely applied.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group consisted of the group to which a tubular bandage was placed over the routinely applied peripheral intravenous catheters. Receives: Combination Product: tubular bandage |
| control group | No intervention | The routine practice used for the application of peripheral intravenous catheters in the ward constituted the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
pediatric peripheral infiltration scale, information collection form
The effect of tubular bandage on infiltration and catheter use time in children will be analyzed.
Measured: about a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start10 Feb 2024
- Primary completion30 Sep 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
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.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, DİLEK SÖNMEZ SAĞLIK, Istanbul University
- Investigators
- dilek sönmez sağlık, Principal investigator, dilek.sonmez@istanbul.edu.tr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579820
- Sponsor's protocol ID
- DSONMEZSAGLIK
- Acronym
- chıldren
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marsh N, Larsen EN, Takashima M, Kleidon T, Keogh S, Ullman AJ, Mihala G, Chopra V, Rickard CM. Peripheral intravenous catheter failure: A secondary analysis of risks from 11,830 catheters. Int J Nurs Stud. 2021 Dec;124:104095. doi: 10.1016/j.ijnurstu.2021.104095. Epub 2021 Sep 26.
PubMed 34689013Santos LMD, Conceicao TB, Silva CSGE, Tavares SS, Rocha PK, Avelar AFM. Care related to peripheral intravenous catheterism in pediatrics performed by nursing technicians. Rev Bras Enferm. 2021 Oct 18;75(2):e20200611. doi: 10.1590/0034-7167-2020-0611. eCollection 2021. English, Portuguese.
PubMed 34669898Ullman AJ, Takashima M, Kleidon T, Ray-Barruel G, Alexandrou E, Rickard CM. Global Pediatric Peripheral Intravenous Catheter Practice and Performance: A Secondary Analysis of 4206 Catheters. J Pediatr Nurs. 2020 Jan-Feb;50:e18-e25. doi: 10.1016/j.pedn.2019.09.023. Epub 2019 Oct 21.
PubMed 31648879Huang LS, Huang Y, Hu J. Current practices of peripheral intravenous catheter fixation in pediatric patients and factors influencing pediatric nurses' knowledge, attitude and practice concerning peripheral intravenous catheter fixation: a cross-sectional study. BMC Nurs. 2021 Nov 23;20(1):236. doi: 10.1186/s12912-021-00758-1.
PubMed 34814906Corley 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 31629208Corley A, Marsh N, Ullman AJ, Rickard CM. Peripheral intravenous catheter securement: An integrative review of contemporary literature around medical adhesive tapes and supplementary securement products. J Clin Nurs. 2023 May;32(9-10):1841-1857. doi: 10.1111/jocn.16237. Epub 2022 Feb 3.
PubMed 35118759Bahl A, Gibson SM, Jankowski D, Chen NW. Short peripheral intravenous catheter securement with cyanoacrylate glue compared to conventional dressing: A randomized controlled trial. J Vasc Access. 2023 Jan;24(1):52-63. doi: 10.1177/11297298211024037. Epub 2021 Jun 11.
PubMed 34112019Alexandrou E, Ray-Barruel G, Carr PJ, Frost SA, Inwood S, Higgins N, Lin F, Alberto L, Mermel L, Rickard CM; OMG Study Group. Use of Short Peripheral Intravenous Catheters: Characteristics, Management, and Outcomes Worldwide. J Hosp Med. 2018 May 30;13(5). doi: 10.12788/jhm.3039.
PubMed 29813140
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Tubular Bandage Application on Peripheral Intravenous Catheter Usage Time and Infiltration in Children
- ClinicalTrials.gov ID
- NCT06579820
- Acronym / sponsor ID
- chıldren / DSONMEZSAGLIK
- Conditions
- Child, Only
- Keywords
- child, infiltration,catheter usage time
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 30 Sep 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 30 Aug 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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Combination Product: tubular bandageThe experimental group consisted of the group to which a tubular bandage was placed over the routinely applied peripheral intravenous catheters. |
| control group | No intervention | –The routine practice used for the application of peripheral intravenous catheters in the ward constituted the control group. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- Coagulation abnormalities
- Receiving blood and blood products through the peripheral venous catheter
- Nutritional issues
- Hematologic or oncologic diseases
- Congenital genetic or neurological disorders
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 |
|---|---|---|
| tubular bandageThe experimental group consisted of the group in which a tubular bandage was applied over the PIC, which was routinely applied. | Combination product | experimental group |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Background: PubMed 34689013Marsh N, Larsen EN, Takashima M, Kleidon T, Keogh S, Ullman AJ, Mihala G, Chopra V, Rickard CM. Peripheral intravenous catheter failure: A secondary analysis of risks from 11,830 catheters. Int J Nurs Stud. 2021 Dec;124:104095. doi: 10.1016/j.ijnurstu.2021.104095. Epub 2021 Sep 26.
- Background: PubMed 34669898Santos LMD, Conceicao TB, Silva CSGE, Tavares SS, Rocha PK, Avelar AFM. Care related to peripheral intravenous catheterism in pediatrics performed by nursing technicians. Rev Bras Enferm. 2021 Oct 18;75(2):e20200611. doi: 10.1590/0034-7167-2020-0611. eCollection 2021. English, Portuguese.
- Background: PubMed 31648879Ullman AJ, Takashima M, Kleidon T, Ray-Barruel G, Alexandrou E, Rickard CM. Global Pediatric Peripheral Intravenous Catheter Practice and Performance: A Secondary Analysis of 4206 Catheters. J Pediatr Nurs. 2020 Jan-Feb;50:e18-e25. doi: 10.1016/j.pedn.2019.09.023. Epub 2019 Oct 21.
- Background: PubMed 34814906Huang LS, Huang Y, Hu J. Current practices of peripheral intravenous catheter fixation in pediatric patients and factors influencing pediatric nurses' knowledge, attitude and practice concerning peripheral intravenous catheter fixation: a cross-sectional study. BMC Nurs. 2021 Nov 23;20(1):236. doi: 10.1186/s12912-021-00758-1.
- 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 35118759Corley A, Marsh N, Ullman AJ, Rickard CM. Peripheral intravenous catheter securement: An integrative review of contemporary literature around medical adhesive tapes and supplementary securement products. J Clin Nurs. 2023 May;32(9-10):1841-1857. doi: 10.1111/jocn.16237. Epub 2022 Feb 3.
- Background: PubMed 34112019Bahl A, Gibson SM, Jankowski D, Chen NW. Short peripheral intravenous catheter securement with cyanoacrylate glue compared to conventional dressing: A randomized controlled trial. J Vasc Access. 2023 Jan;24(1):52-63. doi: 10.1177/11297298211024037. Epub 2021 Jun 11.
- Background: PubMed 29813140Alexandrou E, Ray-Barruel G, Carr PJ, Frost SA, Inwood S, Higgins N, Lin F, Alberto L, Mermel L, Rickard CM; OMG Study Group. Use of Short Peripheral Intravenous Catheters: Characteristics, Management, and Outcomes Worldwide. J Hosp Med. 2018 May 30;13(5). doi: 10.12788/jhm.3039.
- Individual participant dataSharing planned: No
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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.
dilek sönmez sağlık principal investigator
dilek.sonmez@istanbul.edu.tr
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tubular bandage in people with Child, Only, run by Istanbul University at 2 sites 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 7 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact dilek sönmez sağlık (0 0507 338 39 97, dilek.sonmez@istanbul.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pediatric peripheral infiltration scale, information collection form (time frame: about a year). 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 NCT06579820, 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 30 Aug 2024.