Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System

NCT07046624 | Not Yet Recruiting DMC

• 1 other identifier: 2025/34
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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%.

Conditions

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

Outcome Measures

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.

  From enrollment to the end of treatment at 10 monts

Secondary Outcomes (2)

• Peripheral Edema Scale

  From enrollment to the end of treatment at 10 monts

• Glasgow Coma Scale

  From enrollment to the end of treatment at 10 monts

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Group where no intervention will be applied

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

Experimental group

EXPERIMENTAL

The group to which the intervention will be applied

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

Interventions

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.

Control Group; Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Unconscious patients

Sponsors & Collaborators

• Ordu University: lead

Related Links

• Remote patient monitoring: a comprehensive study
• Design and Development of Patient Monitoring System

MeSH Terms

Conditions

Phlebitis

Interventions

Patient Care

Condition Hierarchy (Ancestors)

Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis

Intervention Hierarchy (Ancestors)

Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fatma Aksoy, MscN

  Ordu University

  PRINCIPAL INVESTIGATOR

• Şule Bıyık Bayram, PhD

  Karadeniz Technical University

  STUDY DIRECTOR

Central Study Contacts

Fatma Aksoy, MScN

CONTACT

+905389529328; fatma.aksoyy96@gmail.com

Şule Bıyık Bayram, PhD

CONTACT

sulebiyik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In blinding the results, only the person performing the analysis will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 10, 2025
• First Posted: July 1, 2025
• Study Start: November 8, 2025
• Primary Completion: June 8, 2026
• Study Completion (Estimated): July 8, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.