Comparison Between Early and Late Post-operative Mobilization Following Implantation of Cardiac Pacemaker or Defibrillator
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 主要终点
- Lead dislodgement
研究概览
简要总结
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvenience to the patients.
详细描述
Mobilization after cardiac implantable electronic devices (CIED) implantation is highly variable between centers, some discharging home after 3-4 hours while others request bed restriction for 24 hours. Concern about lead dislodgements due to early mobilization are probably not justified. Bed restriction may result in considerable inconvinience to the patients.
Patients will be randomally assigned to early mobilization (after 4 hours) or bed restriction till the morning after the procedure.
Primary outcome: lead malfunction, patients' satisfaction
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •All patients undergoing device implantation and are hemodynamically stable
排除标准
- •hemodincamically unstable
- •patient's request
研究组 & 干预措施
early mobilization after cardiac device implantation
mobilization after 4 hours
干预措施: mobilization (Other)
Late mobilization after cardiac device implantation
Mobilization after 24 hours
干预措施: mobilization (Other)
结局指标
主要结局
Lead dislodgement
时间窗: one month
incidence of device lead dislodgement
次要结局
- Patients' comfort level(one month)
研究者
Asaf Danon
Principal investigator
Carmel Medical Center