The Effect of Catheter Protector on Catheter Dwell Time and Complications
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorKaramanoğlu Mehmetbey University
About this trial
Objective: This study aimed to determine the effect of applying the IV House Ultradressing catheter protector on the frequency of peripheral venous catheter (PVC) replacements and complications in patients with peripheral venous catheterization in an oncology clinic.
Materials and Methods: The research was planned as a randomized controlled experimental study. The population of the study consisted of patients hospitalized in the oncology clinic. The sample of the study was calculated based on the data from the study by Büyükyılmaz et al. (2019), which found a significant difference in the average duration of catheter-related phlebitis in the intervention group (2.10 ± 1.55 days) compared to the control group (1.27 ± 0.45 days), with an effect size of d=0.72. As a result of the sample size calculation, 32 patients were predicted for each group. Considering that 10% of patients might drop out during the study, a total of 70 patients, with 35 in each group, were decided to be included. After the catheter is inserted, patients in the intervention group will have their catheter area protected with IV House Ultradressing, while no protective measures will be applied to the control group. Both groups will be evaluated in terms of catheter duration and PVC complications. It is planned to use t-tests and chi-square tests for data analysis.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Inclusion Criteria
Hospitalized in the oncology clinic
The one with the PVK attached,
Volunteered to participate in the research,
Disqualifiers
- With a clotting disorder,
Patients with problems with skin integrity or limb movement such as scar tissue, infection, hematoma, edema at the PVK site,
Blood or blood products given through a catheter,
Patients who wanted to leave, were referred to a different clinic or discharged during the study were excluded from the study.
Trial design
Design model
Parallel
Treatments tested in this trial
I.V. House UltraDressing
DeviceI.V. House UltraDressing (I.V. House, Inc., St. Louis, MO, USA) will be applied according to the manufacturer's instructions and secured with an anti-slip tape without the need for further taping. It is intended to prevent complications such as catheter-related displacement, phlebitis, infiltration, extravasation, catheter occlusion, and folding of PVCs.
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: I.V. House UltraDressingExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Phlebitis Follow up Form
The scale includes grading steps from 0 to 4, with observation of symptoms that can be seen at each stage of phlebitis. With this scale, phlebitis is evaluated as: * Grade 0: no symptoms, * Grade 1: redness and/or pain at the catheter entry site, * Grade 2: redness, pain and/or edema at the catheter entry site, * Grade 3: redness, pain and/or edema at the catheter entry site, red line, palpation of the vein in the form of a cable, Grade 4: redness, pain and/or edema at the catheter entry site, red line, palpation of the vein in the form of a cable and longer than 2.5 cm, purulent discharge.
Time frame
up to 1 weeks2
PIVC Length of Stay Follow up Form
The purpose of this form is to determine how many days PIVC remains in the patient. The form includes the items for day 0, day 1, day 2, day 3, day 4, day 5, day 6 and day 7.
Time frame
up to 1 weeks3
Infiltration Follow up Form
The purpose of this form will be used to determine infiltration. The form includes "yes" and "no" items. After the catheter is assessed by observation and palpation, the present item will be marked if there is infiltration, and the absent item will be marked if there is no infiltration.
Time frame
up to 1 weeks4
Extravasation Follow up Form
The purpose of this form will be used to determine extravasation. The form includes "yes" and "no" items. After the catheter is assessed by observation and palpation, the present item will be marked if there is extravasation, and the absent item will be marked if there is no extravasation.
Time frame
up to 1 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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