InfiltrationNCT07649499
The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-related Infiltration and Phlebitis in the Pediatric Emergency Department
A study testing Care Bundle for PIVC Management in people with Infiltration and Intravenous, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This quasi-experimental study evaluates the effectiveness of a care bundle in preventing peripheral intravenous catheter (PIVC)-related infiltration and phlebitis in pediatric emergency department patients. Read more about this study
- Who is it for?
- Ages 28 days to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Infiltration, Intravenous, Phlebitis
- What is being tested?
- Care Bundle for PIVC Management
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2024to 12 May 2025
- 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 28 days to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children admitted to the Pediatric Emergency Department
- First-time peripheral intravenous catheter (PIVC) insertion Ages between 28 days to 18 years
- At least 6 hours of observation after catheter insertion
- Fluid administration in the observation area (e.g., 5% dextrose + 0.45% NaCl + 5/10 cc potassium)
- Written informed consent obtained from parents/legal guardians
- Children willing to participate in the study
Who cannot join
- Children with skin problems (e.g., epidermolysis bullosa)
- Children allergic to products used in the care bundle
- Children who have undergone procedures that could cause catheter displacement or infiltration (e.g., lumbar puncture) Children with chronic vascular issues (e.g., vasculitis, hematologic disorders, congenital vascular anomalies)
- Children transferred to intensive care or another department after PIVC insertion
- Children with clinical conditions that prevent standard care bundle application (e.g., extreme agitation, inability to immobilize extremities)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dr. Sadi Konuk Eğitim ve Araştırma Hastanesi
Istanbul
About this study
Official title: The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-Related Infiltration and Phlebitis in the Pediatric Emergency Department: A Quasi-Experimental Study
This quasi-experimental study evaluates the effectiveness of a care bundle in preventing peripheral intravenous catheter (PIVC)-related infiltration and phlebitis in pediatric emergency department patients. The care bundle includes interventions such as nurse education, hand hygiene, aseptic techniques, and the use of antiseptic solutions (2% chlorhexidine and 70% alcohol) for PIVC insertion and maintenance. The study compares the incidence of infiltration and phlebitis between the intervention and control groups.
Read the detailed description
This study was conducted in the Pediatric Emergency Department of Dr. Sadi Konuk Education and Research Hospital, involving 200 pediatric patients, with 100 in the intervention group and 100 in the control group. The intervention group received a care bundle, which included education on peripheral intravenous catheter management, hand hygiene, aseptic techniques, and the use of antiseptic solutions (2% chlorhexidine and 70% alcohol). The control group received standard care according to routine practice. The incidence of infiltration and phlebitis was compared between the groups, with data collected using the Visual Infusion Phlebitis Assessment Scale (VIPAS) and Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).
- Conditions
- Infiltration, Intravenous, Phlebitis, Pediatrics, Intravenous Catheters
- Being tested
- Care Bundle for PIVC Management
- Keywords
- Peripheral Intravenous Catheter, Care Bundle, Infiltration, Phlebitis, Pediatric Emergency, Nurse Education
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Bundle for PIVC ManagementBehavioural
The intervention group will receive a care bundle designed to reduce peripheral intravenous catheter (PIVC)-related complications (infiltration and phlebitis). The bundle includes the following components:
Nurse Education: Training on PIVC management and best practices.
Hand Hygiene: Emphasis on proper hand hygiene before and after each insertion and maintenance procedure.
Aseptic Techniques: Strict adherence to aseptic technique during PIVC insertion and maintenance.
Antiseptic Solutions: Use of 2% chlorhexidine and 70% alcohol for skin preparation and catheter insertion.
Stabilization: Use of hydrocolloid transparent adhesive bandages for catheter fixation to prevent dislodgement and reduce irritation.
Insertion Attempts: Limiting the number of attempts to a maximum of two to reduce trauma to the insertion site.
Monitoring and Documentation: Regular assessment of the PIVC site for complications and accurate documentation by nursing staff.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group (Care Bundle) | Experimental | The intervention group will receive a care bundle consisting of the following:
Nurse Education on peripheral intravenous catheter (PIVC) management.
Hand Hygiene and adherence to aseptic techniques during PIVC insertion.
Use of 2% chlorhexidine and 70% alcohol antiseptic solutions for PIVC insertion.
Hydrocolloid transparent adhesive bandage for stabilization of the catheter.
Nurses will avoid performing more than two attempts for PIVC insertion.
Aseptic technique will be strictly followed during PIVC insertion and maintenance. Receives: Behavioral: Care Bundle for PIVC Management |
| Control Group (Standard Care) | No intervention | The control group will receive standard care as per routine practice in the pediatric emergency department: Standard peripheral intravenous catheter (PIVC) insertion procedures as performed by clinical staff. No additional interventions such as nurse education or the specific antiseptic solutions or stabilization methods will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Peripheral Intravenous Catheter-Related Infiltration
The primary outcome is the incidence of PIVC-related infiltration in pediatric patients. Infiltration will be assessed using the Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).
Measured: From the time of catheter insertion to 6 hours post-insertion
Incidence of Peripheral Intravenous Catheter-Related Phlebitis
the incidence of PIVC-related phlebitis. Phlebitis will be assessed using the Visual Infusion Phlebitis Assessment Scale (VIPAS).
Measured: From the time of catheter insertion to 6 hours post-insertion.
Secondary outcomes (3)
First Attempt Success Rate for PIVC Insertion
The percentage of successful PIVC insertions on the first attempt.
Measured: Procedure (During initial PIVC insertion attempt.)
Number of PIVC Insertions
The total number of PIVC insertion attempts for each patient.
Assessment Method: Clinical record review.
Measured: At the time of PIVC insertion procedure
Nurse Adherence to Care Bundle Protocol
The degree to which nurses adhere to the care bundle protocol (hand hygiene, aseptic techniques, antiseptic use, etc.).
Assessment Method: Adherence checklists and observation by researchers
Measured: At the time of PIVC insertion procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start1 Jan 2024
- Primary completion1 Jun 2024
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfiltrationStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gizem Çolak, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649499
- Sponsor's protocol ID
- GizemPIVC2025
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on sharing individual participant data will be made once the study is completed and analyzed. Ethical considerations will guide this decision.
Publications
Suliman M, Saleh W, Al-Shiekh H, Taan W, AlBashtawy M. The Incidence of Peripheral Intravenous Catheter Phlebitis and Risk Factors among Pediatric Patients. J Pediatr Nurs. 2020 Jan-Feb;50:89-93. doi: 10.1016/j.pedn.2019.11.006. Epub 2019 Nov 27.
PubMed 31785409
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Care Bundle in Preventing the Frequency of Peripheral Intravenous Catheter-Related Infiltration and Phlebitis in the Pediatric Emergency Department: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07649499
- Acronym / sponsor ID
- GizemPIVC2025
- Conditions
- Infiltration, Intravenous, Phlebitis, Pediatrics, Intravenous Catheters
- Keywords
- Peripheral Intravenous Catheter, Care Bundle, Infiltration, Phlebitis, Pediatric Emergency, Nurse Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 16 Jun 2026 (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.
This quasi-experimental study evaluates the effectiveness of a care bundle in preventing peripheral intravenous catheter (PIVC)-related infiltration and phlebitis in pediatric emergency department patients. The care bundle includes interventions such as nurse education, hand hygiene, aseptic techniques, and the use of antiseptic solutions (2% chlorhexidine and 70% alcohol) for PIVC insertion and maintenance. The study compares the incidence of infiltration and phlebitis between the intervention and control groups.
Detailed description
This study was conducted in the Pediatric Emergency Department of Dr. Sadi Konuk Education and Research Hospital, involving 200 pediatric patients, with 100 in the intervention group and 100 in the control group. The intervention group received a care bundle, which included education on peripheral intravenous catheter management, hand hygiene, aseptic techniques, and the use of antiseptic solutions (2% chlorhexidine and 70% alcohol). The control group received standard care according to routine practice. The incidence of infiltration and phlebitis was compared between the groups, with data collected using the Visual Infusion Phlebitis Assessment Scale (VIPAS) and Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (Care Bundle) | Experimental | Behavioral: Care Bundle for PIVC ManagementThe intervention group will receive a care bundle consisting of the following: Nurse Education on peripheral intravenous catheter (PIVC) management. Hand Hygiene and adherence to aseptic techniques during PIVC insertion. Use of 2% chlorhexidine and 70% alcohol antiseptic solutions for PIVC insertion. Hydrocolloid transparent adhesive bandage for stabilization of the catheter. Nurses will avoid performing more than two attempts for PIVC insertion. Aseptic technique will be strictly followed during PIVC insertion and maintenance. |
| Control Group (Standard Care) | No intervention | –The control group will receive standard care as per routine practice in the pediatric emergency department: Standard peripheral intravenous catheter (PIVC) insertion procedures as performed by clinical staff. No additional interventions such as nurse education or the specific antiseptic solutions or stabilization methods will be applied. |
Who may qualify
- Ages
- 28 days to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Children admitted to the Pediatric Emergency Department
- First-time peripheral intravenous catheter (PIVC) insertion Ages between 28 days to 18 years
- At least 6 hours of observation after catheter insertion
- Fluid administration in the observation area (e.g., 5% dextrose + 0.45% NaCl + 5/10 cc potassium)
- Written informed consent obtained from parents/legal guardians
Key exclusion criteria (5 listed)
- Children with skin problems (e.g., epidermolysis bullosa)
- Children allergic to products used in the care bundle
- Children who have undergone procedures that could cause catheter displacement or infiltration (e.g., lumbar puncture) Children with chronic vascular issues (e.g., vasculitis, hematologic disorders, congenital vascular anomalies)
- Children transferred to intensive care or another department after PIVC insertion
- Children with clinical conditions that prevent standard care bundle application (e.g., extreme agitation, inability to immobilize extremities)
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 |
|---|---|---|
| Care Bundle for PIVC ManagementThe intervention group will receive a care bundle designed to reduce peripheral intravenous catheter (PIVC)-related complications (infiltration and phlebitis). The bundle includes the following components: Nurse Education: Training on PIVC management and best practices. Hand Hygiene: Emphasis on proper hand hygiene before and after each insertion and maintenance procedure. Aseptic Techniques: Strict adherence to aseptic technique during PIVC insertion and maintenance. Antiseptic Solutions: Use of 2% chlorhexidine and 70% alcohol for skin preparation and catheter insertion. Stabilization: Use of hydrocolloid transparent adhesive bandages for catheter fixation to prevent dislodgement and reduce irritation. Insertion Attempts: Limiting the number of attempts to a maximum of two to reduce trauma to the insertion site. Monitoring and Documentation: Regular assessment of the PIVC site for complications and accurate documentation by nursing staff. | Behavioural | Intervention Group (Care Bundle) |
Primary outcome
Incidence of Peripheral Intravenous Catheter-Related Infiltration
Time frame: From the time of catheter insertion to 6 hours post-insertion
The primary outcome is the incidence of PIVC-related infiltration in pediatric patients. Infiltration will be assessed using the Pediatric Peripheral Intravenous Infiltration Scale (PPIIS).
Incidence of Peripheral Intravenous Catheter-Related Phlebitis
Time frame: From the time of catheter insertion to 6 hours post-insertion.
the incidence of PIVC-related phlebitis. Phlebitis will be assessed using the Visual Infusion Phlebitis Assessment Scale (VIPAS).
3 secondary outcomes
First Attempt Success Rate for PIVC Insertion
Time frame: Procedure (During initial PIVC insertion attempt.)
Number of PIVC Insertions
Time frame: At the time of PIVC insertion procedure
Nurse Adherence to Care Bundle Protocol
Time frame: At the time of PIVC insertion procedure
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 16 Jun 2026.
- Background: PubMed 31785409Suliman M, Saleh W, Al-Shiekh H, Taan W, AlBashtawy M. The Incidence of Peripheral Intravenous Catheter Phlebitis and Risk Factors among Pediatric Patients. J Pediatr Nurs. 2020 Jan-Feb;50:89-93. doi: 10.1016/j.pedn.2019.11.006. Epub 2019 Nov 27.
- Individual participant dataSharing planned: Undecided. A decision on sharing individual participant data will be made once the study is completed and analyzed. Ethical considerations will guide this decision.
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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 Care Bundle for PIVC Management in people with Infiltration and Intravenous, run by Istanbul University - Cerrahpasa 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 6 inclusion and 5 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 16 Jun 2026. 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?
Incidence of Peripheral Intravenous Catheter-Related Infiltration (time frame: From the time of catheter insertion to 6 hours post-insertion). The study lists 2 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 NCT07649499, which also lists 1 linked publication.
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 16 Jun 2026.