Development of an Arterial Pressure Monitoring Set Fixation Apparatus and Evaluation of Its Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Accuracy of Invasive Blood Pressure and Central Venous Pressure Measurements
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
盲法说明
The study is not blinded; participants and investigators know which intervention is used.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Arterial Pressure Monitoring Set Fixation Device (Device)
结局指标
主要结局
Accuracy of Invasive Blood Pressure and Central Venous Pressure Measurements
时间窗: 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.
次要结局
未报告次要终点
研究者
Zeynep Gürkan
Research Assistant and PhD Candidate
Yuzuncu Yil University