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首页> 外文期刊>BMJ Open >Postoperative vascular complications in unrecognised Obstructive Sleep apnoea (POSA) study protocol: an observational cohort study in moderate-to-high risk patients undergoing non-cardiac surgery
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Postoperative vascular complications in unrecognised Obstructive Sleep apnoea (POSA) study protocol: an observational cohort study in moderate-to-high risk patients undergoing non-cardiac surgery

机译:无法识别的阻塞性睡眠呼吸暂停(POSA)研究方案中的术后血管并发症:一项在非心脏手术中至高危患者中的观察性队列研究

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Introduction Emerging epidemiological data suggest that obstructive sleep apnoea (OSA) is common in the general surgical population. Unfortunately, the majority of these patients are unrecognised and untreated at the time of surgery. There is substantial biological rationale to indicate that patients with unrecognised OSA are at a higher risk of postoperative vascular events. However, the extent of this morbidity is currently unknown. We have initated the postoperative vascular complications in the unrecognised obstructive sleep apnoea (POSA) study to determine the associations between OSA, nocturnal hypoxia and major postoperative vascular events in 1200 moderate-to-high risk patients undergoing major non-cardiac surgery. Methods and analysis The POSA study is an international prospective observational cohort study. Using a type 3 portable sleep monitoring device and ambulatory oximetry, we will quantify the severity of OSA. The primary outcome is a composite of vascular death, myocardial infarction; non-fatal cardiac arrest; stroke; pulmonary embolism; congestive heart failure and new arrhythmia within 30?days of surgery. As of November 2013, we have recruited over 700 patients from nine centres in six countries. The mean age is 68?years, the mean body mass index is 27?kg/m2 and 55% of patients are men. 27.9% of patients have known coronary artery disease, over 76% have diabetes. The majority of patients underwent orthopaedic surgery (28%) and colorectal resection (18.5%). Ethics and dissemination The POSA study has received ethics approval from all study sites before patient recruitment. Informed consent will be obtained from all patients. The POSA study will determine the risk of unrecognised OSA in major non-cardiac surgery. We will publish these findings in peer-reviewed journals. Trial Registration: ClinicalTrials.gov Identifier: NCT01494181 Study design We have initiated the postoperative complications in the unrecognised obstructive sleep apnoea (POSA) study—an international prospective, observational study in 1200 patients with known, or at risk of, atherosclerotic disease undergoing major non-cardiac surgery to determine the association between OSA and postoperative vascular events. We hypothesised that patients with unrecognised OSA had a higher rate of postoperative vascular events than those who did not.
机译:简介新兴的流行病学数据表明,阻塞性睡眠呼吸暂停(OSA)在普通外科手术人群中很常见。不幸的是,这些患者中的大多数在手术时未被识别和治疗。有充分的生物学原理表明未识别OSA的患者发生术后血管事件的风险更高。但是,这种发病率的程度目前未知。我们已经在未识别的阻塞性睡眠呼吸暂停(POSA)研究中启动了术后血管并发症,以确定OSA,夜间缺氧与1200例接受大范围非心脏手术的中高风险患者的主要术后血管事件之间的关联。方法和分析POSA研究是一项国际前瞻性观察队列研究。使用3型便携式睡眠监测设备和动态血氧饱和度测定法,我们将量化OSA的严重程度。主要结局是血管死亡,心肌梗死的综合结果;非致命性心脏骤停;中风;肺栓塞手术后30天内出现充血性心力衰竭和新的心律不齐。截至2013年11月,我们已从六个国家/地区的9个中心招募了700多名患者。平均年龄为68岁,平均体重指数为27?kg / m 2 ,55%的患者为男性。 27.9%的患者已知冠状动脉疾病,超过76%的患者患有糖尿病。大多数患者接受了整形外科手术(28%)和大肠切除术(18.5%)。伦理和传播POSA研究在招募患者之前已获得所有研究地点的伦理批准。将获得所有患者的知情同意。 POSA研究将确定大型非心脏手术中未被识别的OSA的风险。我们将在同行评审的期刊上发表这些发现。试验注册:ClinicalTrials.gov标识符:NCT01494181研究设计我们已经在未识别的阻塞性睡眠呼吸暂停(POSA)研究中启动了术后并发症的研究,这项研究是一项针对1200例已知或有动脉粥样硬化疾病正经历重大非手术风险的患者的国际前瞻性观察性研究。心脏手术,以确定OSA与术后血管事件之间的关联。我们假设未发现OSA的患者术后血管事件的发生率高于未发现OSA的患者。

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