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NCT Number: NCT07046624

Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System

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%.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • Unconscious patients

Treatment and study plan

Infusion monitoring system developed for use by nurses in patient care

Behavioral

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.

Primary outcomes

  1. Complication Follow-up Form

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

    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.

Secondary outcomes

  1. Peripheral Edema Scale

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

    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.

  2. Glasgow Coma Scale

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Aksoy, MScN

CONTACT

[email protected]

+905389529328

Şule Bıyık Bayram, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Ordu University

Other

Registry information

Official study title

Development of an Infusion Monitoring System to Prevent Phlebitis, Infiltration and Extravasation and Its Application in the Intensive Care Unit

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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