The Cardiac Stress and Electrocardiographic Changes Caused by Lung Cancer Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Postoperative P-wave, QRS-complex, and T-wave axle changes
研究概览
简要总结
Lung cancer surgery causes significant changes in the small circulation as well as changes in the intrathoracic anatomy. The effects of lung cancer surgery on electrocardiography and the cardiac stress associated with the procedures have not been previously extensively studied. The aim of the present study is to ascertain whether modern mini-invasive lung cancer surgery causes changes in the electrocardiogram, and whether these changes are transitory during short-term follow-up. Furthermore, the study aims to describe whether lung cancer surgery causes significant cardiac stress detectable by intraoperative electrocardiography.
详细描述
Lung cancer surgery causes significant acute changes in the small circulation as well as both transient and permanent changes in the intrathoracic anatomy. The electrocardiographic changes as well as their associations with postoperative recovery associated with modern mini-invasive lung cancer surgery have not been extensively studied.
The aims of the study are:
- To define in detail the electrocardiographic changes and their duration caused by lung cancer surgery, both perioperatively and in the early postoperative period
- To assess, whether perioperative electrocardiographic changes are associated with the postoperative recovery of these patients.
Altogether 100 patients with planned mini-invasive lung cancer surgery in the Tays Heart Hospital, Tampere, Finland, will be prospectively recruited for the study between the years 2021 and 2028.
The 12-lead rest electrocardiogram will be recorded from each patient preoperatively as well daily postoperatively and during follow-up out-patient clinic visit two weeks postoperatively. The perioperative continuous multi-lead electrocardiogram will be recorded. Laboratory examinations (cardiac troponins and natriuretic peptides) indicating cardiac stress will be obtained from the patients preoperatively and repeatedly postoperatively. The variables included in the electrocardiography analysis include cardiac rhythm, heart rate variability, PQ-time, QRS duration, P-, QRS, and T-wave amplitudes and axles, as well as ST-level variations.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients scheduled for elective lung cancer surgery
- •Willing to participate in the study
- •Curatively aimed surgery
- •Preoperative decision for mini-invasive surgery
排除标准
- •Participation in any other clinical trial
- •Previous chronic or paroxysmal atrial fibrillation or atrial flutter
- •Cardiac pacemaker
- •History of cardiac conduction disturbances including bundle branch blocks
- •History of cardiac ablation procedures
- •History of previous surgery in the thoracic area including open heart surgery
- •Preoperatively anticipated need for concomitant thoracic wall resection
- •Preoperatively anticipated need for open surgery
结局指标
主要结局
Postoperative P-wave, QRS-complex, and T-wave axle changes
时间窗: 2 weeks
The occurrence and type of P-wave, QRS-complex, and T-wave axle changes in the postoperative 12-lead rest electrocardiogram
Postoperative QRS-duration
时间窗: 2 weeks
The duration of the QRS-complex in milliseconds in the electrocardiogram, measured daily postoperatively using 12-lead rest electrocardiogram.
Postoperative PQ-delay
时间窗: 2 weeks
Changes in the PQ-delay in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.
Postoperative QT-interval
时间窗: 2 weeks
The duration of QT-interval in milliseconds in the 12-lead rest electrocardiogram measured daily postoperatively.
Postoperative heart rate
时间窗: 1 week
Postoperative heart rate variability in continuous electrocardiographic monitoring
Postoperative ST-level changes
时间窗: 3 days
ST-level changes in millimeters in the 12-lead rest electrocardiogram
Perioperative heart rate variability
时间窗: 1 day
Heart rate levels perioperatively in the continuous perioperative electrocardiographic monitoring.
Perioperative arrhythmias
时间窗: 1 day
The occurrence and type of perioperative arrhythmias, such as atrial fibrillation or flutter, or ventricular tachycardia in the perioperative electrocardiographic monitoring.
Postoperative electrocardiographic p-, R-, and T-wave amplitude changes
时间窗: 2 weeks
Amplitude changes in the 12-lead rest electrocardiography in millimeters, analyzed daily postoperatively.
The postoperative incidence of new bundle branch blocks
时间窗: 2 weeks
New complete or partial bundle branch blocks, such as RBBB, in the 12-lead rest electrocardiogram.
Perioperative ST-level changes
时间窗: 1 day
The occurrence, duration (in minutes) as well as the magnitude (in millimeters) of perioperative ST-elevation or depression in the continuous perioperative electrocardiographic monitoring.
Postoperative arrhythmias
时间窗: 1 week
Arrhythmia rate as well as their type during the early postoperative period detected by continuous electrocardiogram monitoring
Perioperative R- and T-wave amplitude changes
时间窗: 1 day
The amplitude (in millimeters) of possible R- and T-wave amplitude changes in the perioperative electrocardiographic monitoring.
次要结局
- Postoperative air leak(1 week)
- Need for reoperation(1 week)