Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Absolute incidence of postoperative atrial fibrillation
研究概览
简要总结
Atrial fibrillation (AF) is a common and serious complication after lung resection. The incidence is likely underestimated, and risk may persist after leaving hospital. Recent development of simple wearable patch ECG devices may provide sensitive detection of AF in the extended postoperative period. Specific biomarkers may allow us to predict which patients are at risk of developing postoperative AF.
详细描述
Postoperative atrial fibrillation (POAF) is a serious complication that can occur after thoracic surgery. A substantial proportion of AF is clinically silent, detectable only by ECG monitoring. Despite the lack of symptoms, it is still associated with increased risk of stroke, and may partly explain the risk of postoperative mortality after discharge from hospital.
No studies have been completed investigating the occurrence of AF in an extended period of monitoring following non-cardiac surgery, including thoracic surgery. In the limited literature on extended ECG monitoring following cardiac surgery, recurrent AF affected 24% of patients after discharge from hospital, and only 30% had symptoms. In total, 49% of patients in these studies had POAF up to two weeks after surgery.
Detection of POAF increases with more intensive monitoring. Therefore investigators believe that the incidence of POAF is underestimated, and extended monitoring using a patch ECG device will allow increased detection of clinically evident and silent POAF.
Investigators will place CardioSTAT (Icentia Inc, QC, Canada) patch ECG devices on patients immediately after thoracic surgery. They will be worn for two weeks continuously, following which they are returned by mail to the manufacturer. These devices are simple to apply and can be worn even in the shower and while exercising. Technologist interpretation is provided by the manufacturer, and will be corroborated by our study cardiologist.
Patients will also wear the patch ECG for 14 days prior to surgery. This will provide information on how many patients have silent AF at baseline, and will make it possible to determine whether AF after surgery is new or is an exacerbation of a pre-existing but unknown condition.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients, age ≥ 55 years at time of surgery, undergoing thoracic surgery with general anesthesia
- •Co-enrolment in the NT-proBNP biomarker monitoring study
排除标准
- •Patients with a prior history of documented AF
- •Patients with an implanted pacemaker or defibrillator
- •Patients currently taking anti-arrhythmic medication other than ß- blockers, calcium channel blockers or digoxin
- •Patients undergoing minor thoracic interventions/procedures (i.e., minor chest-wall surgeries, chest tube insertions, or needle pleural/lung biopsies)
- •Patients who are unable or unwilling to wear the CardioSTAT device as per manufacturer's guidelines, or who are unable/unwilling to return the device via mail to Icentia for procession and analysis
- •Patients with known allergy to adhesives
结局指标
主要结局
Absolute incidence of postoperative atrial fibrillation
时间窗: 14 days postop
Detected by device
次要结局
- Rate of accrual relative to the number of eligible patients per month(6-month recruitment period)
- 90-day mortality(90 days following surgery)
- Incidence of stroke(90 days following surgery)
- Atrial fibrillation burden(14 days postop)
- Incidence of preoperative subclinical atrial fibrillation(14 days within 6 weeks prior to surgery)
- Adherence to study protocol: Number of patients completing full 14-day use of CardioSTAT device(14 days preop, 14 days postop)
- Adherence to study protocol: Number of days CardioSTAT device worn per patient(14 days postop)
- Adherence to study protocol: Number of patients completing symptom journal(14 days postop)