An observational study in All Patients with Peripheral Venous Catheters, sponsored by Karamanoğlu Mehmetbey University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by Karamanoğlu Mehmetbey University · Observational
Among 12 studies in Phlebitis with a site in Turkey — none open to participants now, none under way, none of them phase 3. Phlebitis · Turkey.
Among the 12 studies in Phlebitis with a site in Turkey, this one is the only one that started in 2021, is one of 3 observational ones, and was the 8th registered.
45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.
Browse Phlebitis studies →None of the 12 studies in Phlebitis with a site in Turkey is open now.
Of the 4 Phlebitis studies recruiting now, 3 (75%) set no upper age limit and 0 (0%) stop at 75 or younger; 0 take children under 18; 1 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2020; this study’s year is marked. 1 started in 2021.
Median enrollment 75 across the 9 interventional studies, 116 across the 3 observational. Of the 12 that completed or were terminated, 0 (0%) have results posted.
None of the 12 has an industry lead sponsor. The 8 most frequent:
Karamanoğlu Mehmetbey University is the lead sponsor of 69 studies on the registry; 19 are open to participants now.
Karamanoğlu Mehmetbey University has 2 studies filed under Phlebitis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 12 studies in Phlebitis with a site in Turkey, from their registry updates:
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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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
Time frame: The evaluation took an average of 6 months until the completion of the study.
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
No publications or documents are linked to this record.
Ran from Sep 2021 to primary completion in Sep 2021, 0 months.
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This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Karamanoğlu Mehmetbey University