Safety and Benefits of Mobilization at 4 Hours Compared to 24 Hours After Implantation of an Intracardiac Electronic Device: a Randomized Clinical Trial of Non-inferiority, Open and Controlled in Parallel Groups
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 558
- 试验地点
- 1
- 主要终点
- Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion
研究概览
简要总结
Bedrest is usually prescribed for patients management after cardiac electronic device implantation (CIED) in order to prevent complication. Due to the lack of guidelines available on the timing of postoperative mobilization management, the aim of the study is to evaluate the safety of early mobilization, comparing mobilization at 4-h against day-after procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •≥ 18 years old
- •Signed informed consent form
- •New permanent pacemaker implantation (PM) or implantable cardioverter-defibrillator (ICD)
排除标准
- •CIED implants after recent cardiac surgery
- •Upgrade or revision of implanted device
- •CRT implantation
- •Intraoperative complications
研究组 & 干预措施
Mobilization 4-h after procedure
Short-term bed-rest (4-h) after CIED implantation
干预措施: Early mobilization (Other)
Mobilization day-after procedure
Standard of care with prolungate bed-rest after CIED implantation
干预措施: Standard of care (Other)
结局指标
主要结局
Composite endpoint: pacing lead dislodgement, pocket hematoma, pneumothorax, and pericardial effusion
时间窗: Within 48 hours post operative
Incidence of post-operatory complications (composite endpoint). Non inferiority margin 5%
次要结局
- Post-operative pain(24 hours)
- Sleep disturbance(The first night after surgery)
- Quality of recovery(Day 1)
- Post-operative pain(24 hours)
- Sleep disturbance(The first night after surgery)
- Number of participants with postoperative urinary retention(Within 24 hours post operative)
- Number of participants developing postoperative delirium(Within 24 hours post operative)
- Number of participants developing orthostatic intolerance(First out-of-bed mobilization)
- Quality of recovery(Day 1)
- Number of participants developing pressure ulcer(Within 48 hours post operative)
研究者
Caporali Elena
Principal Investigator
Ente Ospedaliero Cantonale, Bellinzona