Cerebral Oxygen Saturation Measurement During Cardioversion Because of Atrial Fibrillation
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
- Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion
研究概览
简要总结
Near infrared spectroscopy (NIRS) is a technique that measures regional cerebral oxygenation in a non-invasive manner. Through the use of near infrared light, the difference between oxygenated and deoxygenated hemoglobin can be measured. By applying the Lambert-Beer law, a numeric result can be calculated.
Since atrial fibrillation (AF) has been linked with an increased risk for the development of neurocognitive deficits, a longer period of AF might be associated with a higher risk for neurocognitive deficits.
It is hypothesized that there is an increase in the regional cerebral oxygen saturation (rSO2) of patients with paroxysmal or persistent AF after successful cardioversion.
详细描述
Written informed consent by the patient is asked before cardioversion and participation in the study. Patient anamnesis is assessed by standardized questionnaire.
Patients perform several standardised neurocognitive tests to obtain a general view on the neurocognitive status (auditory verbal learning test, mini-mental state examination, trail making A and B, digit-symbol coding and RAND 36 Health Survey).
Cerebral oxygenation is observed during cardioversion by means of the SenSmart Model X-100 (Nonin). Additional parameters (pulse oximetry, cardiac output, arterial blood pressure, 6-lead electrocardiography (ECG), left ventricular ejection fraction) are recorded. All measurements are performed non-invasively. Patients receive standard treatment following the clinical guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18 years and able to give informed consent
- •diagnosis of paroxysmal or persistent atrial fibrillation
- •scheduled for electrical cardioversion or atrial fibrillation development in the first days after cardiac surgery followed by pharmacological treatment with amiodarone
- •Dutch speaking
排除标准
- •younger than 18 years or not able to give informed consent
- •diagnosis of permanent atrial fibrillation
- •atrial fibrillation with thrombus in left atrial appendage
- •chronic obstructive pulmonary disease GOLD class 3 or 4
- •airway manipulation during cardioversion
- •pregnant women
- •medical history of cerebrovascular accident or brain injury
- •medical history of cardiopulmonary resuscitation
结局指标
主要结局
Measure the cerebral saturation changes in response to electrical/pharmacological cardioversion
时间窗: 6 months
次要结局
- Compare the changes in cerebral oxygen saturation with the left ventricular ejection fraction(6 months)
- Relate the responses of cerebral saturation, regional saturation, pulse oximetry and blood pressure with each other(6 months)
- Perform neuropsychological tests before and after electrical/pharmacological cardioversion(6 months)
- Compare the response of the pulse oximetry with the effects on the neurocognitive status(6 months)
- Measure the time for recuperation of cerebral saturation after a period of decreased cerebral saturation(6 months)
- Compare the response of the blood pressure with the effects on the neurocognitive status(6 months)
- Compare the response of the cerebral/regional saturation with the effects on the neurocognitive status(6 months)
研究者
Cornelia Genbrugge
MD
Hasselt University