Development of an Arterial Pressure Monitoring Set Fixation Apparatus

Not Applicable

Recruiting

• Conditions: Coronary Artery Bypass Graft Surgery

• Registration Number: NCT07035756
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

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.

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 Timeline

• Study Start: 2025-01-27
• Status Verified: 2025-06
• Study First Submitted: 2025-06-12
• Study First Submitted QC: 2025-06-20
• Last Update Submitted: 2025-06-20
• Study First Posted: 2025-06-25
• Last Update Posted: 2025-06-25
• Primary Completion: 2025-06-30
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Accuracy of Invasive Blood Pressure and Central Venous Pressure Measurements	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.

Trial Locations

Locations (1)

Van Training and Research Hospital; 🇹🇷 Van, Turkey