Development of an Arterial Pressure Monitoring Set Fixation Apparatus

Yuzuncu Yıl University

Status: Enrolling

Conditions: Coronary Artery Bypass Graft Surgery

Treatments: Device: Arterial Pressure Monitoring Set Fixation Device

Study type: Interventional

Funder types: Other

Identifiers

NCT07035756

TDK-2024-14774 (Other Grant/Funding Number)

2024/08-09

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Arterial Pressure Monitoring Set Fixation Device Group

Experimental group

Description:

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.

Treatment:

Device: Arterial Pressure Monitoring Set Fixation Device