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NCT Number: NCT07035756

Development of an Arterial Pressure Monitoring Set Fixation Apparatus

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Van Training and Research Hospital

Van, 65000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arterial Pressure Monitoring Set Fixation Device

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Yuzuncu Yil University

Other

Collaborators

  • Ataturk University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2025
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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