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Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07046624
Enrollment
102
Registered
2025-07-01
Start date
2025-11-08
Completion date
2026-07-08
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief 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%.

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.

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.

Sponsors

Ordu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

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

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Complication Follow-up FormFrom enrollment to the end of treatment at 10 montsThis 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

MeasureTime frameDescription
Peripheral Edema ScaleFrom enrollment to the end of treatment at 10 montsIt 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.
Glasgow Coma ScaleFrom enrollment to the end of treatment at 10 montsThis 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.

Contacts

Primary ContactFatma Aksoy, MScN
fatma.aksoyy96@gmail.com+905389529328
Backup ContactŞule Bıyık Bayram, PhD
sulebiyik@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026