Evolution of the Severity of Obstructive Sleep Apnea and Consequences on Cardiac Rhythm Abnormalities After Surgery Under General Anesthesia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Change from baseline in heart rhythm troubles linked to hypoxemia events
研究概览
简要总结
Higher risk of cardiac and respiratory post-operative events is observed in patients with unrecognised Obstructive Sleep Apnea (OSA). The efficiency of a simple method of OSA screening by analysing ventilation with measurement of nose pressure and nocturnal hypoxemia (oxygen desaturation index) will be assessed. These sleep respiratory analyses will be compared with the research of arrhythmia, in order to show if they are linked to the hypoxemia events.
Aggravation of nocturnal respiratory disorder and higher incidence of cardiac and respiratory postoperative complications will be assessed in OSA patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •orthopaedic, urologic, vascular, digestive surgery
- •under general anaesthesia or sedation
- •age > 45 years old
- •STOP-BANG score>3
排除标准
- •Head and neck surgery, planned prolonged mechanical ventilation after surgery (>24h)
- •Severe COPD
- •Post-operative ICU planned
- •Diagnosed OSA or other sleep disorder breathing
结局指标
主要结局
Change from baseline in heart rhythm troubles linked to hypoxemia events
时间窗: Before surgery and at first and third night after surgery
Heart rhythm troubles will be assessed 3 times: * First time = baseline assessment, during one night before surgery * second assessment will occur during the first night after surgery * last assessment will take place during the third night after surgery
次要结局
- Change from baseline OSA prevalence and cardiorespiratory complications after surgery(Before surgery and at first and third night after surgery)
- Aggravation of cardiac events linked to hypoxemia(After surgery from night 1 to night 15 maximum)
- Change from baseline in severity of OSA defined by the oxygen saturation index(Before surgery and at first and third night after surgery)