NCT03136614Unknown不适用
Prognostic Value of the Arteriograph in the Surgical Theatre and at the Intensive Care Unit
Szeged University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2016年6月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Correlation between systemic vascular resistance and aortic augmentation index
研究概览
简要总结
To investigate how pulse wave velocity, aortic augmentation index and the arterial pulse wave given by the Arteriograph contributes to preoperative assesment, intraoperative and intensive care monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
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
- 是
入选标准
- •For the "preoperative" arm:
- •Signed informed consent form
- •Arterial catheter for hemodynamic monitoring
- •For the "intraoperative" arm:
- •Signed informed consent form
- •Arterial catheter for hemodynamic monitoring
- •The operation will presumably last for more than 2 hours
- •For the "intensive care unit" arm:
- •Signed informed consent form
- •PiCCO monitor for hemodynamic monitoring
排除标准
- •For the "preoperative" arm:
- •Pregnancy
- •Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
- •For the "intraoperative" arm:
- •Pregnancy
- •Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
- •Measuring blood pressure on both arms is not possible
- •Insertion of an arterial catheter is not necessary or contraindicated
- •Insertion of a central venous catheter is not necessary or contraindicated
- •For the "intensive care unit" arm:
- •Pregnancy
- •Subject belongs to a vulnerable group (ISO 14155:2011) e.g.: study member, medical student
结局指标
主要结局
Correlation between systemic vascular resistance and aortic augmentation index
时间窗: One year
Identity of cardiac output given by the PiCCO monitor and cardiac output given by the Arteriograph
时间窗: One year
Number and degree of hypotensive episodes predicted by preoperative values of pulse wave velocity.
时间窗: One year
The investigators will examine if high values of pulse wave velocity correlate with the frequency and severity of hypotensive episodes under anaesthesia.
次要结局
未报告次要终点
研究者
Zsolt Molnár, MD, PhD, DEAA
clinician
Szeged University
研究点 (2)
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