Development of an Infusion Monitoring System to Prevent Phlebitis, Infiltration and Extravasation and Its Application in the Intensive Care Unit
Phase: NA
Conditions: Extravasation, Intensive Care Units (ICUs), Phlebitis, Infiltration
Sponsor: Ordu University

Development and Implementation of an Infusion Monitoring System to 
Prevent Phlebitis, Infiltration, and Extravasation in the Intensive Care Unit 
 
 
08.08.2025 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Title: Development of Infusion Monitoring System to Prevent Phlebitis, Infiltration and 
Extravasation and Its Application in Intensive Care Unit  
Introduction  
This study was planned to evaluate the effectiveness of the infusion monitoring system created to prevent 
complications that may develop frequently during or after drug infusion in clinics. The study aims to 
reduce the incidence of phlebitis, infiltration and extravasation in Ordu State Hospital General Intensive 
Care 1 and General Intensive Care 3 clinics. These two clinics have similar patient profiles and treatment 
plans are carried out by the same physicians. In the first stage of the study, the infusion tracking system 
will be designed and the software will be created. Then, the infusion monitoring system will be used by 
the nurses and its effectiveness will be evaluated. The nurses in the clinic in the control group will follow 
their routine procedures in patient care.   
Method  
Aim and type of the study  
The aim of this study was to create an infusion monitoring system and evaluate its effectiveness in the 
early detection of peripheral intravenous catheter-related complications. The study was planned as a 
randomised controlled experimental study.   
Research Hypotheses H01: Infusion monitoring system has no effect on the prevention of phlebitis 
among peripheral intravenous catheter-related complications.  
H11: Infusion monitoring system has no effect on the prevention of phlebitis among peripheral 
intravenous catheter-related complications.  
H02: The infusion monitoring system has no effect on the prevention of infiltration, one of the 
complications associated with peripheral intravenous catheters.  
H12: The infusion monitoring system is effective in preventing infiltration, one of the complications 
associated with peripheral intravenous catheters.  
H03: The infusion monitoring system has no effect on the prevention of extravasation, one of the 
complications associated with peripheral intravenous catheters.  
H13: The infusion monitoring system is effective in preventing extravasation, one of the complications 
associated with peripheral intravenous catheters.  
Population and Sample of the Study  
The population of the study will consist of two intensive care units. The final sample size will be 
determined by a G*Power analysis following a two-month pilot observation period. A preliminary 

sample size estimation was conducted before initiating the study. Based on a 95% confidence level (1-
α), a 5% margin of error, and an incidence rate of 10.68%, the minimum required number of cases to be 
included in the study was determined to be 102. The validity and reliability of the infusion monitoring 
system developed for this study will also be tested.  
Inclusion criteria: Patients aged 18 and above, receiving medication through a peripheral intravenous 
catheter, monitored daily for signs of phlebitis, infiltration, and extravasation, and who are conscious 
and able to respond, will be included in the study.  
Exclusion criteria: Patients who are unconscious and unable to respond will be excluded from the 
study.  
Data Collection and Instruments Data Collection Forms 
The data will be collected using the following forms developed by the researcher through literature 
review:  
• Clinical Monitoring Form  
• Patient Information Form  
• Complication Monitoring Form  
• Peripheral Edema Scale  
• Glasgow Coma Scale  
Application Tools Development of the Infusion Monitoring System 
The infusion monitoring system software will be developed as a technological tool to improve nurses’ 
peripheral infusion monitoring skills, increase awareness, and reduce the incidence of peripheral venous 
catheter complications such as phlebitis, infiltration, and extravasation.  
Implementation and Data Collection Process  
Before the study begins, the infusion monitoring system software will be developed and made 
operational. In the pilot phase, a preliminary observation will be carried out in the designated clinics to 
determine the baseline incidence of complications. In the implementation phase, the use of the infusion 
monitoring system by nurses and its effectiveness will be evaluated.  
Pilot Implementation of the Study 
 During the pilot implementation, complications related to peripheral venous catheters will be monitored 
in both the experimental and control clinics for a period of two months, aiming to observe a total of 102 
catheters. Subsequently, nurses in both intensive care clinics will receive training on correct catheter 

placement, prevention strategies, and maintenance. The usability of the infusion monitoring system will 
be tested by installing the application on mobile devices (smartphones/tablets) used by two nurses in the 
experimental group. The nurses will use the application for one day during patient care, and their 
feedback regarding the usability and technical performance of the system will be collected for necessary 
improvements.  
Study Implementation Phase  
Each nurse will use the application on their own smartphone/tablet or another technological device. 
Nurses will use the electronic infusion monitoring system during patient care for one month. Afterward, 
the incidence rates of peripheral venous catheter complications will be reevaluated in both the control 
and experimental clinics using the same two-month monitoring protocol with 102 catheter observations. 
It is expected that the use of the infusion monitoring system will allow nurses to monitor infusion 
initiation, termination, and intervals more efficiently, enabling faster decision-making and optimized 
interventions for preventing and managing complications. As a result, it is anticipated that patient safety 
will increase, and the quality of care processes will improve. The control group will continue routine 
care procedures without the use of the system.  
Data Analysis  
The collected data will be transferred into the computer using the Statistical Package for Social Sciences 
(SPSS) version 23.0. Sociodemographic characteristics will be analyzed using frequency and percentage 
distributions. Data from the data collection forms will be analyzed using Pearson/Spearman correlation 
tests. Normality of the data will be assessed with the One-Sample Kolmogorov–Smirnov test. Within-
group comparisons will be conducted using ANOVA/Friedman tests, and betweengroup comparisons 
across days will be analyzed with ANOVA/Kruskal-Wallis tests. All data will be evaluated at a 
significance level of p<0.05 with a 95% confidence interval.  
Ethical Considerations 
 Before starting the study, ethical approval was obtained from the Scientific Research Ethics Committee 
of Karadeniz Technical University, Faculty of Health Sciences (Ethics Committee Approval No: the 
2025/34 – Date: 09.05.2025). All patients and their relatives included in the study were informed about 
the purpose and plan of research and provided both written and verbal informed consent. At all stages 
of the study, the principles of the Declaration of Helsinki were strictly followed.