All Patients with Peripheral Venous CathetersNon-randomizedNCT06743399
Care Bundle Applıcation in the Prevention of Phlebitis
An observational study of All Patients with Peripheral Venous Catheters, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a non-randomized controlled trial, comprising both experimental and control groups, to evaluate the efficacy of an evidence-based care bundle in preventing the development of peripheral venous catheter-related phlebitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- All Patients with Peripheral Venous Catheters
- How many people
- 116 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2021to 30 Mar 2022
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants in the study are individuals who have received inpatient treatment for at least 72 hours in the Internal Medicine/Wound Care Clinic and Neurology/Neurosurgery clinics of Karaman Training and Research Hospital, Turkiye have undergone PVK application in the specified clinics, do not have existing phlebitis, have no bleeding, clotting, or circulatory disorders (as determined from patient records), are not receiving immunosuppressive therapy, chemotherapy, or radiotherapy, are aged 18 or older, and have voluntarily agreed to participate in the study.
Who may be able to join
- Received inpatient treatment for at least 72 hours Internal Medicine/Wound Care Clinic and Neurology/Neurosurgery clinics,
- PVK is applied in specified clinics,
- No existing phlebitis,
- No bleeding, clotting or circulatory disorders (learned from patient records),
- Not receiving immunosuppressive, chemotherapy and radiotherapy treatments,
- 18 years and above,
- Patients who volunteered to participate in the study were included in the study.
Who cannot join
- Transferred to another clinic,
- Died during the research process,
- (For experimental group patients) Failure to fully comply with the care package,
- Patients who wanted to leave the study after agreeing to participate in the study were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Karamanoğlu Mehmetbey Üniversitesi Sağlık Hizmetleri MYO
Karaman, Karaman, 70000
About this study
Official title: The Effect of Evidence-Based Care Bundle Applıcatıon in the Prevention of Peripheral Venous Catheter-Related Phlebitis Development
This study was designed as a non-randomized controlled trial, comprising both experimental and control groups, to evaluate the efficacy of an evidence-based care bundle in preventing the development of peripheral venous catheter-related phlebitis. The study was conducted at a goverment hospital, specifically within the Internal Diseases/Injury Care and Neurology/Neurosurgery Departments. Data collection involved the use of several instruments: the Nurse Descriptive Characteristics Form, the Patient Demographic and Clinical Information Form, the Phlebitis Evaluation Scale, and the Bundle Care Clinical Follow-up Form. Patients in the control group received standard care as per the clinic's protocols, while nurses were trained in the principles of care, phlebitis management, and the implementation of care bundles. Patients in the experimental group received care according to the evidence-based care bundle prepared for this study. Statistical analysis of the data was performed using Chi-square and Fisher's Exact tests. Care bundle application was found to be effective in decreasing the rate of PVC-related phlebitis development.
Read the detailed description
Peripheral venous catheterization (PVC) is a procedure that involves the insertion of a cannula into the lumen of a vein through the patient's skin. It is among the most commonly performed invasive nursing interventions in hospitalized patients. PVC is utilized at various stages of care for approximately 80% of patients during their hospital stay, serving multiple purposes, including meeting their fluid requirements, maintaining fluid-electrolyte balance, administering pharmacological treatments, transfusing blood and blood products, providing total parenteral nutrition (TPN), ensuring vascular access, and monitoring hemodynamic parameters.
When performed appropriately, PVC is a valuable procedure that can be lifesaving for patients. However, improper application or inadequate catheter care can lead to significant local complications, such as infiltration, extravasation, and hemorrhage, as well as systemic complications, including embolism, infection, and circulatory overload. Among these complications, phlebitis, characterized by pain and tenderness along the vein due to inflammation of the intima layer, is particularly common. A variety of factors contribute to the development of phlebitis. Individual factors include advanced age, gender, neutropenia, malnutrition, cancer, cardiovascular diseases, immunosuppression, existing infections, diabetes, smoking, confusion, dementia, and impaired consciousness. Mechanical factors involve the type and size of catheter, the duration of catheter placement, and the anatomical site of insertion. Chemical factors encompass the pH and osmolarity of fluids, as well as the introduction of antiseptic solutions into the vein. Additionally, procedural factors such as the frequency of set changes, maintenance of aseptic conditions, care of the catheter site, and the type of dressing materials used also play a significant role in the incidence of phlebitis.
The Infusion Nurses Society (INS) and the Infusion Nurses Association (INA) recommend that the incidence of phlebitis in a specified patient population should remain below 5%. However, the literature indicates that the incidence of phlebitis varies widely, with reported rates ranging from 1.25% to 80%. In specific studies conducted in our country, the incidence of phlebitis has been reported to be considerably higher, ranging from 17% to 67%. This variability may be attributed to differences in healthcare practices, infection control measures, and patient demographics.
Phlebitis is a common but preventable complication in clinical practice. Enhancing the quality of care to prevent such complications has led to the prominence of care bundles, which are structured sets of clinical practices aimed at preventing specific complications or improving particular clinical outcomes. The care bundle approach entails the simultaneous and complete implementation of scientifically validated practices, applied in a step-by-step manner. Resarch indicates that the application of these practices as a cohesive whole yields better outcomes compared to their individual application. Each component of a care bundle should consist of commonly accepted practices that are supported by evidence, preferably derived from randomized controlled trials classified at evidence levels I and II. Maintaining high compliance with care bundle protocols enhances their effectiveness and overall quality of care, ultimately contributing to reductions in both mortality and morbidity.
Researches that the application of care bundles leads to improved clinical outcomes. Studies have been demonstrated implementation of care bundles significantly reduces the incidence of ventilator-related pneumonia (VRP) and central venous catheterization-related blood circulation infections (CVCR-BCI).
Null Hypothesis (H0) = The application of evidence-based care bundles does not affect the prevention of the development of peripheral venous catheter-related phlebitis.
Alternative Hypothesis (H₁) = The application of evidence-based care bundles positively affects the prevention of peripheral venous catheter-related phlebitis.
In this study, a non-randomized controlled trial was designed and executed, incorporating both control and experimental groups. The methodology followed the guidelines of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for case-control studies.
- Keywords
- Peripheral venous catheterization., phlebitis, nursing,, care bundle,, experimental study.
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | The experimental group included patients who received training, follow-up care, and the care bundle. Patients provided consent, completed demographic forms, and their PVC applications were assessed daily using the "Phlebitis Care Bundle Follow-up Form." Full compliance with all care bundle parameters was required, and non-compliant patients were excluded. Nurses received feedback, and phlebitis symptoms were recorded daily. Monitoring continued until catheter removal or patient discharge. Data collection took place daily from 09:00-12:00, lasting about 2.5 hours. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phlebitis Care Bundle Clinical Follow-up Form
This form was developed to track and record the daily application of nursing interventions from the evidence-based care bundle designed to prevent the development of PVC-related phlebitis.
Measured: The evaluation took an average of 6 months until the completion of the study.
Phlebitis Evaluation Scale
The Phlebitis Evaluation Scale developed by the Intravenous Nursing Society (2006) was used to assess phlebitis symptoms in the area where PVC was placed. The scale ranges from 0 to 4, where 0 indicates no symptoms, 1 indicates redness and/or pain in the catheter entry point, 3 indicates redness, pain, and/or edema at the catheter entry point, red line, and palpation of the vein as a cable, and 4 includes symptoms such as redness, pain, and/or edema at the catheter entry point, red line, palpation of the vein as a cable, being longer than 2.5 cm, and purulent drainage. The researcher observes the PVC area and determines the degree of phlebitis.
Measured: The evaluation took an average of 6 months until the completion of the study.
Peripheral Venous Catheter Observation
The form, created by the researcher, was designed to daily record the phlebitis symptoms and degree included in the Phlebitis Evaluation Scale
Measured: The evaluation took an average of 6 months until the completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2024
- Study start1 Sep 2021
- Primary completion1 Sep 2021
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for All Patients with Peripheral Venous CathetersStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba DOST, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06743399
- Sponsor's protocol ID
- Karamanoglu Mehmetbey U
- Acronym
- Non-randomized
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Evidence-Based Care Bundle Applıcatıon in the Prevention of Peripheral Venous Catheter-Related Phlebitis Development
- ClinicalTrials.gov ID
- NCT06743399
- Acronym / sponsor ID
- Non-randomized / Karamanoglu Mehmetbey U
- Keywords
- Peripheral venous catheterization., phlebitis, nursing,, care bundle,, experimental study.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 19 Dec 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.
This study was designed as a non-randomized controlled trial, comprising both experimental and control groups, to evaluate the efficacy of an evidence-based care bundle in preventing the development of peripheral venous catheter-related phlebitis. The study was conducted at a goverment hospital, specifically within the Internal Diseases/Injury Care and Neurology/Neurosurgery Departments. Data collection involved the use of several instruments: the Nurse Descriptive Characteristics Form, the Patient Demographic and Clinical Information Form, the Phlebitis Evaluation Scale, and the Bundle Care Clinical Follow-up Form. Patients in the control group received standard care as per the clinic's protocols, while nurses were trained in the principles of care, phlebitis management, and the implementation of care bundles. Patients in the experimental group received care according to the evidence-based care bundle prepared for this study. Statistical analysis of the data was performed using Chi-square and Fisher's Exact tests. Care bundle application was found to be effective in decreasing the rate of PVC-related phlebitis development.
Detailed description
Peripheral venous catheterization (PVC) is a procedure that involves the insertion of a cannula into the lumen of a vein through the patient's skin. It is among the most commonly performed invasive nursing interventions in hospitalized patients. PVC is utilized at various stages of care for approximately 80% of patients during their hospital stay, serving multiple purposes, including meeting their fluid requirements, maintaining fluid-electrolyte balance, administering pharmacological treatments, transfusing blood and blood products, providing total parenteral nutrition (TPN), ensuring vascular access, and monitoring hemodynamic parameters.
When performed appropriately, PVC is a valuable procedure that can be lifesaving for patients. However, improper application or inadequate catheter care can lead to significant local complications, such as infiltration, extravasation, and hemorrhage, as well as systemic complications, including embolism, infection, and circulatory overload. Among these complications, phlebitis, characterized by pain and tenderness along the vein due to inflammation of the intima layer, is particularly common. A variety of factors contribute to the development of phlebitis. Individual factors include advanced age, gender, neutropenia, malnutrition, cancer, cardiovascular diseases, immunosuppression, existing infections, diabetes, smoking, confusion, dementia, and impaired consciousness. Mechanical factors involve the type and size of catheter, the duration of catheter placement, and the anatomical site of insertion. Chemical factors encompass the pH and osmolarity of fluids, as well as the introduction of antiseptic solutions into the vein. Additionally, procedural factors such as the frequency of set changes, maintenance of aseptic conditions, care of the catheter site, and the type of dressing materials used also play a significant role in the incidence of phlebitis.
The Infusion Nurses Society (INS) and the Infusion Nurses Association (INA) recommend that the incidence of phlebitis in a specified patient population should remain below 5%. However, the literature indicates that the incidence of phlebitis varies widely, with reported rates ranging from 1.25% to 80%. In specific studies conducted in our country, the incidence of phlebitis has been reported to be considerably higher, ranging from 17% to 67%. This variability may be attributed to differences in healthcare practices, infection control measures, and patient demographics.
Phlebitis is a common but preventable complication in clinical practice. Enhancing the quality of care to prevent such complications has led to the prominence of care bundles, which are structured sets of clinical practices aimed at preventing specific complications or improving particular clinical outcomes. The care bundle approach entails the simultaneous and complete implementation of scientifically validated practices, applied in a step-by-step manner. Resarch indicates that the application of these practices as a cohesive whole yields better outcomes compared to their individual application. Each component of a care bundle should consist of commonly accepted practices that are supported by evidence, preferably derived from randomized controlled trials classified at evidence levels I and II. Maintaining high compliance with care bundle protocols enhances their effectiveness and overall quality of care, ultimately contributing to reductions in both mortality and morbidity.
Researches that the application of care bundles leads to improved clinical outcomes. Studies have been demonstrated implementation of care bundles significantly reduces the incidence of ventilator-related pneumonia (VRP) and central venous catheterization-related blood circulation infections (CVCR-BCI).
Null Hypothesis (H0) = The application of evidence-based care bundles does not affect the prevention of the development of peripheral venous catheter-related phlebitis.
Alternative Hypothesis (H₁) = The application of evidence-based care bundles positively affects the prevention of peripheral venous catheter-related phlebitis.
In this study, a non-randomized controlled trial was designed and executed, incorporating both control and experimental groups. The methodology followed the guidelines of the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines for case-control studies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | –The experimental group included patients who received training, follow-up care, and the care bundle. Patients provided consent, completed demographic forms, and their PVC applications were assessed daily using the "Phlebitis Care Bundle Follow-up Form." Full compliance with all care bundle parameters was required, and non-compliant patients were excluded. Nurses received feedback, and phlebitis symptoms were recorded daily. Monitoring continued until catheter removal or patient discharge. Data collection took place daily from 09:00-12:00, lasting about 2.5 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants in the study are individuals who have received inpatient treatment for at least 72 hours in the Internal Medicine/Wound Care Clinic and Neurology/Neurosurgery clinics of Karaman Training and Research Hospital, Turkiye have undergone PVK application in the specified clinics, do not have existing phlebitis, have no bleeding, clotting, or circulatory disorders (as determined from patient records), are not receiving immunosuppressive therapy, chemotherapy, or radiotherapy, are aged 18 or older, and have voluntarily agreed to participate in the study.
Key inclusion criteria (7 listed)
- Received inpatient treatment for at least 72 hours Internal Medicine/Wound Care Clinic and Neurology/Neurosurgery clinics,
- PVK is applied in specified clinics,
- No existing phlebitis,
- No bleeding, clotting or circulatory disorders (learned from patient records),
- Not receiving immunosuppressive, chemotherapy and radiotherapy treatments,
Key exclusion criteria (4 listed)
- Transferred to another clinic,
- Died during the research process,
- (For experimental group patients) Failure to fully comply with the care package,
- Patients who wanted to leave the study after agreeing to participate in the study were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Phlebitis Care Bundle Clinical Follow-up Form
Time frame: The evaluation took an average of 6 months until the completion of the study.
This form was developed to track and record the daily application of nursing interventions from the evidence-based care bundle designed to prevent the development of PVC-related phlebitis.
Phlebitis Evaluation Scale
Time frame: The evaluation took an average of 6 months until the completion of the study.
The Phlebitis Evaluation Scale developed by the Intravenous Nursing Society (2006) was used to assess phlebitis symptoms in the area where PVC was placed. The scale ranges from 0 to 4, where 0 indicates no symptoms, 1 indicates redness and/or pain in the catheter entry point, 3 indicates redness, pain, and/or edema at the catheter entry point, red line, and palpation of the vein as a cable, and 4 includes symptoms such as redness, pain, and/or edema at the catheter entry point, red line, palpation of the vein as a cable, being longer than 2.5 cm, and purulent drainage. The researcher observes the PVC area and determines the degree of phlebitis.
Peripheral Venous Catheter Observation
Time frame: The evaluation took an average of 6 months until the completion of the study.
The form, created by the researcher, was designed to daily record the phlebitis symptoms and degree included in the Phlebitis Evaluation Scale
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 19 Dec 2024.
- Individual participant dataSharing planned: Yes
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?
An observational study of All Patients with Peripheral Venous Catheters, run by Karamanoğlu Mehmetbey 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 7 inclusion and 4 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 19 Dec 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?
Phlebitis Care Bundle Clinical Follow-up Form (time frame: The evaluation took an average of 6 months until the completion of the study.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2024.