Lung Cancer Clinical Trial
Official title:
Continuous Ambulatory ECG Monitoring for Detection of Postoperative Atrial Fibrillation Following Thoracic Surgery
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.
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.
A total of 100 patients will allow a 95% confidence interval of 21-40% around an assumed true
POAF incidence of 30%. The lower limit exceeds conventional estimates of POAF following
thoracic surgery, and would provide strong support for our hypothesis.
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