Development of an Arterial Pressure Monitoring Set Fixation Apparatus

June 20, 2025 updated by: Zeynep Gürkan, Yuzuncu Yıl University

Development of an Arterial Pressure Monitoring Set Fixation Apparatus and Evaluation of Its Effectiveness

This study aims to develop an arterial pressure monitoring set fixation device and evaluate its effectiveness in clinical settings. The device is designed to increase the stability and comfort of arterial pressure monitoring during patient care. An experimental study will be conducted with patients requiring arterial pressure monitoring. The device's effectiveness will be evaluated by measuring fixation stability and postoperative arterial blood pressure-CVP parameters over 48 hours. The study aims to demonstrate that the new fixation device can improve patient safety and monitoring accuracy compared to the standard method using adhesive tape, thereby contributing to better clinical outcomes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study focuses on the development of a novel arterial pressure monitoring set fixation device designed to enhance stability and comfort during invasive arterial pressure measurement. The device securely fixes the monitoring set in place, reducing movement and potential complications caused by displacement or discomfort associated with the adhesive tapes currently in use.

An experimental study design will be employed. Sixty patients requiring postoperative invasive arterial pressure monitoring will be included based on predefined inclusion and exclusion criteria. The fixation device will be applied to these patients.

Fixation stability, patient comfort, and hemodynamic parameters, including arterial blood pressure and central venous pressure (CVP), will be measured over a 48-hour postoperative period. The data will be analyzed to evaluate the device's effectiveness in improving monitoring accuracy and patient safety.

Ethical approval has been obtained from the relevant institutional review board, and compliance with human subject protection standards will be maintained throughout the study.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Van, Turkey, 65000
        • Recruiting
        • Van Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged 18-80 years
  • Patients undergoing arterial catheterization for invasive blood pressure and CVP monitoring
  • Patients able to provide informed consent
  • Hemodynamically stable patients undergoing Coronary Artery Bypass Grafting (CABG)

Exclusion Criteria:

  • Patients younger than 18 or older than 80 years
  • Patients with coagulopathy or bleeding disorders
  • Patients with local infection or skin lesions at the catheter insertion site
  • Patients unable to provide informed consent
  • Hemodynamically unstable patients
  • Patients with known allergy to device materials or adhesive tapes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arterial Pressure Monitoring Set Fixation Device Group
This group includes patients who will receive the new arterial pressure monitoring set fixation device. The device is applied postoperatively to secure arterial pressure monitoring and improve fixation stability and patient comfort over a 48-hour period.
Device: Arterial Pressure Monitoring Set Fixation Device
A newly developed fixation device designed to securely stabilize the arterial pressure monitoring set, improving patient comfort and reducing device displacement during the postoperative period in patients undergoing coronary artery bypass graft surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Invasive Blood Pressure and Central Venous Pressure Measurements
Time Frame: Within the first 48 hours of monitoring
The accuracy of arterial and central venous pressure measurements obtained using the developed fixation device will be compared to those obtained using standard adhesive tape fixation. Accuracy will be determined by evaluating waveform stability and consistency of numeric readings during patient movement and routine care.
Within the first 48 hours of monitoring

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuzuncu Yıl University

Collaborators

Ataturk University

Investigators

  • Principal Investigator: Zeynep Gürkan, Res. Asst., Yuzuncu Yıl University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2025

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

October 31, 2025

Study Registration Dates

First Submitted

June 12, 2025

First Submitted That Met QC Criteria

June 20, 2025

First Posted (Estimated)

June 25, 2025

Study Record Updates

Last Update Posted (Estimated)

June 25, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024/08-09
  • TDK-2024-14774 (Other Grant/Funding Number: Atatürk Univ. Sci. Res. Projects Coord. Unit)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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