ExtravasationNCT07046624
Prevention of Phlebitis, Infiltration and Extravasation With Infusion Monitoring System
A study testing Infusion monitoring system developed for use by nurses in patient care in people with Extravasation and Intensive Care Units (ICUs), run by Ordu University.
Trial 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.. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Extravasation, Intensive Care Units (ICUs), Phlebitis
- What is being tested?
- Infusion monitoring system developed for use by nurses in patient care
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2025to 8 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unconscious patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Şule Bıyık Bayram, PhD contact
About this study
Official title: Development of an Infusion Monitoring System to Prevent Phlebitis, Infiltration and Extravasation and Its Application in the Intensive Care Unit
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%.
Read the 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.
- Conditions
- Extravasation, Intensive Care Units (ICUs), Phlebitis, Infiltration
- Being tested
- Infusion monitoring system developed for use by nurses in patient care
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infusion monitoring system developed for use by nurses in patient careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Group where no intervention will be applied Receives: Behavioral: Infusion monitoring system developed for use by nurses in patient care |
| Experimental group | Experimental | The group to which the intervention will be applied Receives: Behavioral: Infusion monitoring system developed for use by nurses in patient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 10 monts
Secondary outcomes (2)
Peripheral Edema Scale
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.
Measured: From enrollment to the end of treatment at 10 monts
Glasgow Coma Scale
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.
Measured: From enrollment to the end of treatment at 10 monts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start8 Nov 2025 (estimated)
- Primary completion8 Jun 2026 (estimated)
- Study completion8 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExtravasationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The clinics included in the study will be divided into two groups: experimental and control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Aksoy, Ordu University
- Investigators
- Fatma Aksoy, MscN, Principal investigator, Ordu UniversityŞule Bıyık Bayram, PhD, Study director, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046624
- Sponsor's protocol ID
- 2025/34
- Status last verified
- Nov 2025
- First submitted
- 10 Jun 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I just want to share the title of the study. I want the method of the study to remain secret for now since the study is not completed.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Infusion Monitoring System to Prevent Phlebitis, Infiltration and Extravasation and Its Application in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT07046624
- Acronym / sponsor ID
- 2025/34
- Conditions
- Extravasation, Intensive Care Units (ICUs), Phlebitis, Infiltration
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 8 Nov 2025 (estimated)
- Primary completion
- 8 Jun 2026 (estimated)
- Study completion
- 8 Jul 2026 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The clinics included in the study will be divided into two groups: experimental and control.
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Behavioral: Infusion monitoring system developed for use by nurses in patient careGroup where no intervention will be applied |
| Experimental group | Experimental | Behavioral: Infusion monitoring system developed for use by nurses in patient careThe group to which the intervention will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Unconscious patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Infusion monitoring system developed for use by nurses in patient careIn 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. | Behavioural | Control Group, Experimental group |
Primary outcome
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.
2 secondary outcomes
Peripheral Edema Scale
Time frame: From enrollment to the end of treatment at 10 monts
Glasgow Coma Scale
Time frame: From enrollment to the end of treatment at 10 monts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Remote patient monitoring: a comprehensive studyLink provided by the sponsor.
- Design and Development of Patient Monitoring SystemLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. I just want to share the title of the study. I want the method of the study to remain secret for now since the study is not completed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Şule Bıyık Bayram, PhD contact
Fatma Aksoy, MscN principal investigator
Ordu University
Şule Bıyık Bayram, PhD study director
Karadeniz Technical University
Questions about this trial
What is this clinical trial studying?
A study testing Infusion monitoring system developed for use by nurses in patient care in people with Extravasation and Intensive Care Units (ICUs), run by Ordu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma Aksoy, MScN (+905389529328, fatma.aksoyy96@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication Follow-up Form (time frame: From enrollment to the end of treatment at 10 monts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.