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Not yet recruitingNCT07046624Updated Nov 17, 2025

Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System

An interventional study of Infusion monitoring system developed for use by nurses in patient care in Extravasation, Intensive Care Units (ICUs) and Phlebitis, sponsored by Ordu University. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-17.

Sponsored by Ordu University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
102
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Peripheral venous catheter complications are conditions that are frequently seen in intensive care clinics and require nursing care. The most common complications are phlebitis, infiltration and extravasation. Nurses should take the necessary precautions to prevent these complications from developing.. Therefore, this planned thesis study aims to establish an infusion monitoring system and evaluate its effectiveness in early detection of complications related to peripheral intravenous catheters. The research is planned as a randomized controlled experimental study. The study will be conducted in Ordu State Hospital General Intensive Care Unit 1 and General Intensive Care Unit 3 clinics. The universe of the study will consist of patients receiving inpatient treatment in General Intensive Care Unit 1 and General Intensive Care Unit 3 clinics. The sample size will be determined by g-power analysis after a two-month preliminary follow-up. Data will be collected with the "Clinical Follow-up Form", "Patient Information Form", and "Complication Follow-up Form". The clinics included in the study will be divided into two groups as experimental and control groups. First, the frequency of complications will be determined in the experimental and control groups. Then, while the control group continues its routine protocol and applications, an infusion follow-up system will be developed in the experimental group and will be used by nurses in patient care. In the final stage, the frequency of peripheral venous catheter complications will be determined again. Data will be evaluated using the SPSS 22.0 package program at a significance level of p\<0.05 and a confidence interval of 95%.

Read the detailed description

Electronic monitoring systems can increase the quality of care and patient safety by enabling nurses to gain effective care and application techniques and preventing complications that may develop in patients. In addition, the integration of such technologies into clinical practices can enable nurses to act more consciously. This study can lead to the wider application of technology-based solutions in healthcare services by showing the effects of electronic monitoring systems in patient care and complication management in the scientific literature. Reductions in phlebitis, infiltration and extravasation rates improve clinical outcomes by increasing patient safety and increase the quality of life of patients. It is expected that costs will decrease with the increase in the quality of healthcare services and it is aimed to reduce the workload of nurses. Reductions in complication rates can increase the welfare of individuals by allowing patients to recover faster and shorten the duration of hospital stay. In addition, reductions in health-related complications can help reduce healthcare expenses and ease the financial burden of the state and individuals.

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Conditions studied

  • Extravasation
  • Intensive Care Units (ICUs)
  • Phlebitis
  • Infiltration

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03

In context

Phlebitis

45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.

This study's planned enrollment of 102 is below the median of 134 across 38 interventional studies indexed under Phlebitis.

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Lead sponsor

Ordu University is the lead sponsor of 32 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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.

Inclusion criteria

  • 18 years of age and older
  • Receiving medication via peripheral intravenous catheter,
  • Monitored daily for signs of phlebitis, infiltration and extravasation,
  • Patients who can speak

Exclusion criteria

Exclusion Criteria:

  • Unconscious patients
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
102 participants (estimated)

Study arms

  • Active comparator
    Control Group

    Group where no intervention will be applied

    Behavioral: Infusion monitoring system developed for use by nurses in patient care

  • Experimental
    Experimental group

    The group to which the intervention will be applied

    Behavioral: Infusion monitoring system developed for use by nurses in patient care

Interventions

  • BehavioralInfusion monitoring system developed for use by nurses in patient care

    In the experimental group, the frequency of complications will first be determined and an infusion monitoring system will be developed and used by nurses in patient care.

06

What researchers measure

Primary outcomes

  1. Complication Follow-up Form

    This form was developed by the investigators to enable the identification and evaluation of phlebitis, infiltration and extravasation complications. This form has no minimum and maximum score.

    Time frame: From enrollment to the end of treatment at 10 monts

Secondary outcomes

  1. Peripheral Edema Scale

    It helps to diagnose the oedema developing in the patient. A minimum score of 1 and a maximum score of 4 is obtained from the oedema scale. The increase in the score indicates an increase in the degree of oedema and more unfavourable results.

    Time frame: From enrollment to the end of treatment at 10 monts

  2. Glasgow Coma Scale

    This scale allows the patients' level of consciousness to be assessed. Minimum 3 points and maximum 15 points can be obtained from this scale. An increase in the score indicates that the level of consciousness is better, while a decrease in the score indicates that the level of consciousness has worsened.

    Time frame: From enrollment to the end of treatment at 10 monts

07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes — I just want to share the title of the study. I want the method of the study to remain secret for now since the study is not completed.

Supporting information: Study protocol

Time frame: It can start and be published 3 months after the results are published.

Access criteria: The data obtained from the research can be accessed after being analyzed with a suitable statistical program and the results shared.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07046624
Lead sponsor
Ordu University
Responsible party
Fatma Aksoy (Principal Investigator, Ordu University) — Principal investigator
First posted
Jul 1, 2025
Start date
Nov 8, 2025 (estimated)
Primary completion
Jun 8, 2026 (estimated)
Completion
Jul 8, 2026 (estimated)
Last update
Nov 17, 2025

Study contacts

Fatma Aksoy, MScN
Contact
fatma.aksoyy96@gmail.com
+905389529328
Şule Bıyık Bayram, PhD
Contact
sulebiyik@gmail.com
Fatma Aksoy, MscN
principal investigator · Ordu University
Şule Bıyık Bayram, PhD
study director · Karadeniz Technical University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

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