The Effect of Catheter Protector on Catheter Dwell Time and Complications

NCT06675786 | Not Yet Recruiting

• 1 other identifier: Karamanoğlu Mehmetbey üni
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Peripheral Catheterization; Complications

Keywords

Peripheral Venous Catheterization; IV House; Complication; Phlebitis

Outcome Measures

Primary Outcomes (7)

• 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.

  up to 1 weeks

• 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.

  up to 1 weeks

• 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.

  up to 1 weeks

• 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.

  up to 1 weeks

• Occlusion Follow up Form

  This form will be used to determine the occlusion in the PIVC.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 occlusion, and the absent item will be marked if there is no occlusion.

  up to 1 weeks

• Folding Follow up Form

  This form will be used to determine the folding in the PIVC. 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 folding, and the absent item will be marked if there is no folding.

  up to 1 weeks

• Dislocation Follow up Form

  This form will be used to determine PIVC dislocation.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 dislocation, and the absent item will be marked if there is no dislocation.

  up to 1 weeks

Study Arms (2)

I.V. House UltraDressing

EXPERIMENTAL

The nurse who will perform the PVC will clean the area where the PVC will be applied with alcohol and cotton wool, let it dry and apply Teflon Introcan Safety I.V. Catheter No. 22-24 (B. Braun Medical Inc. Bethlehem, PA, USA) to the patients and apply the routine intravenous line fixation method of the clinic with a plaster. The patient with the PVC will then fill out an introductory information form. I.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. Catheter-induced complications such as dislodgement, phlebitis, infiltration, extravasation, catheter occlusion and folding of PVCs will be observed and recorded on the Peripheral Venous Catheter Observation Form and the effect of I.V. House UltraDressing will be evaluated.

Device: I.V. House UltraDressing

Control

NO INTERVENTION

The nurse who will perform the PVC application will clean the area where the PVC will be applied with alcohol and cotton wool and leave it to dry, and the patients in both groups will be applied with a Teflon Introcan Safety I.V. Catheter (B. Braun Medical Inc. Bethlehem, PA, USA) numbered 22-24 and the clinic's routine intravenous line fixation method of fixation with a plaster will be applied. After the PVC is inserted, the introductory information form will be filled out and the duration of the stay of the PVC in the vascular access, dislodgement status and catheter-related complications such as dislodgement, phlebitis, infiltration, extravasation, catheter occlusion and folding of the PVCs will be observed and recorded on the Peripheral Venous Catheter observation form prepared by the researcher. Patients will remain in the study as long as they are hospitalized in the clinic and their PVCs are inserted. The time allocated for each patient is planned to last an average of 15 minut

Interventions

I.V. House UltraDressing DEVICE

I.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.

I.V. House UltraDressing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized in the oncology clinic
• The one with the PVK attached,
• Volunteered to participate in the research,
• Treated in the same clinic during the study period,
• No verbal, perceptual and visual communication problems,
• G (Blue) size catheter used,
• Between the ages of 18 and 65,
• Literate,
• Patients without scar tissue, infection, hematoma, edema at the sites to be used for PVK placement were included in the study.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead

MeSH Terms

Conditions

Phlebitis

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Study Officials

• BETÜL TOSUN, DOÇ. DR.

  Karamanoğlu Mehmetbey University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba DOST, Öğr. Gör. Dr.

CONTACT

+905065031187; t.demiroglu1@gmail.com

Betül TOSUN, Doç. Dr.

CONTACT

+905053652121; tosunbetul@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be informed about the study and their consent will be obtained without revealing which group they are in. A blind technique will also be applied in terms of statistical analysis in the study. Data will be recorded on the computer as Group A and Group B by the researcher without using the terms experimental and control group. Data analyses will be performed by a statistician other than the person who performed the randomization.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: November 5, 2024
• Study Start: November 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: November 5, 2024

Record last verified: 2024-10