NCT06724718招募中不适用
Diagnosis of Atrial Fibrillation in Postoperative Thoracic Surgery Using a Smartwatch
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 302
- 试验地点
- 2
- 主要终点
- the incidence of POAF
研究概览
简要总结
Postoperative atrial fibrillation (POAF) occurs in approximately 20% of patients following thoracic surgery. Early diagnosis is essential to prevent complications such as heart failure, stroke, myocardial infarction, and increased mortality. Smartwatches equipped with single-lead ECG capabilities and algorithms to detect asymptomatic atrial fibrillation (AF) offer a potential solution. This study aims to evaluate the effectiveness of smartwatches in detecting POAF compared to standard care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adults (>18 years old).
- •Patients undergoing major thoracic surgery with one-lung ventilation within the past 48 hours.
- •Scheduled pneumonectomy or lobectomy.
- •Admission to a conventional surgical unit postoperatively.
- •Ability to perform single-lead ECG using a smartwatch.
- •Coverage under a social security system.
- •Signed informed consent
排除标准
- •History of atrial fibrillation.
- •Requirement for telemetry for AV block or tachyarrhythmias (>140 bpm).
- •Dependency on a pacemaker.
- •Participation in another interventional clinical trial affecting POAF incidence.
- •Mediastinal, pleural, or chest wall surgery.
- •Reoperations or surgeries performed more than 48 hours prior.
- •Pregnant women.
- •Patients under guardians or similar legal protection.
结局指标
主要结局
the incidence of POAF
时间窗: at day 7
the incidence of POAF within seven days after scheduled thoracic surgery.
次要结局
- Rate of asymptomatic POAF(at day 7)
- Cardiovascular prognosis(at 6 months)
- Feasibility of rhythm monitoring with a smartwatch(at day 7)
- Recurrence of AF(at 6 months)
- management of AF(at 6 months)
研究者
研究点 (2)
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