Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System

NCT ID: NCT07046624

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-08

Study Completion Date

2026-07-08

Brief Summary

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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%.

Detailed Description

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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.

Conditions

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Extravasation Intensive Care Units (ICUs) Phlebitis Infiltration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The clinics included in the study will be divided into two groups: experimental and control.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
In blinding the results, only the person performing the analysis will be blinded.

Study Groups

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Control Group

Group where no intervention will be applied

Group Type ACTIVE_COMPARATOR

Infusion monitoring system developed for use by nurses in patient care

Intervention Type 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.

Experimental group

The group to which the intervention will be applied

Group Type EXPERIMENTAL

Infusion monitoring system developed for use by nurses in patient care

Intervention Type 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.

Interventions

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Infusion 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ordu University

OTHER

Sponsor Role lead

Responsible Party

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Fatma Aksoy

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fatma Aksoy, MscN

Role: PRINCIPAL_INVESTIGATOR

Ordu University

Şule Bıyık Bayram, PhD

Role: STUDY_DIRECTOR

Karadeniz Technical University

Central Contacts

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Fatma Aksoy, MScN

Role: CONTACT

+905389529328

Şule Bıyık Bayram, PhD

Role: CONTACT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://link.springer.com/article/10.1007/s12652-017-0598-x

Remote patient monitoring: a comprehensive study

https://iopscience.iop.org/article/10.1088/1757-899X/226/1/012094/meta

Design and Development of Patient Monitoring System

Other Identifiers

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2025/34

Identifier Type: -

Identifier Source: org_study_id

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