Safety and Efficacy of an Early Rehabilitation Program in Surgical Intensive Care Unit (SICU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 131
- 主要终点
- 28-day Ventilator-free days (days)
研究概览
简要总结
The purpose of this study is to determine whether an early rehabilitation program in surgical intensive care unit is safe and effective in preventing critical care illness and intensive care unit acquired weakness.
详细描述
Due to the complications like intensive care unit-acquired weakness, critical illness polyneuropathy and neuropsychiatric disease of critical care, many organizations focus on rehabilitation in critically ill patients' management. Despite the good outcomes from papers, there are debatable issues of method, safety and efficacy of rehabilitation. The investigators developed an early rehabilitation program (ERP) in our surgical ICU management and assessed safety and efficacy of it.
The ERP started in November 2014 in our 14-bed surgical ICU in Asan Medical Center. The investigators focused on early and 5-step rehabilitation program for patients who were admitted to SICU for at least 3 days. The investigators enrolled 69 patients (pre-ERP group) for 6 months before November 2014 and 62 patients (post-ERP group) for 6 months 1 year after the ERP started. The main measures were safety issues, delirium days, 28-d ventilator free-days, 28-d ICU free-days, hospital length of stay (LOS), ICU mortality, in-hospital mortality and 1 year mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •patients who were admitted in SICU for at least 3 days
排除标准
- •readmission to SICU within current hospitalization open abdomen wound patients major bone fracture patients brain death patients active bleeding patients increased intra-cranial pressure patients paraplegic patients patients or their guardians did not agree with the ERP doctor's decision (Deconditioning patients, Procedure)
结局指标
主要结局
28-day Ventilator-free days (days)
时间窗: up to 28-day
Patients who died during the study were assigned scores of 0 for 28-day ventilator-free days.
28-day ICU-free days (days)
时间窗: up to 28-day
Patients who died during the study were assigned scores of 0 for 28-day ICU-free days
次要结局
- in-hospital mortality rate (%)(up to 24 weeks)
- 1 year mortality rate (%)(1 year follow up from ICU admission)
- Time to start rehabilitation from ICU admission (days)(up to 2 weeks)
- ICU delirium days (days)(up to 4 weeks)
- Total rehabilitation days within ICU days (days)(up to 4 weeks)
- ICU readmission rate (%)(up to 24 weeks)
- ICU mortality rate (%)(up to 24 weeks)
研究者
Suk-Kyung
Associate professor
Asan Medical Center