Effect Of Acute Inflammatory Mediators On Duration Of Functional Limitations In Patients With Acute Respiratory Failure, A Randomized, Controlled Pilot Study of Early ICU Rehabilitation Strategies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hospital length of stay, days
研究概览
简要总结
This is a randomized, controlled, pilot study of two separate Cohorts of patients from the intensive care unit. Cohort I will enroll 50 patients and randomize to receive one physical therapy session per day or receive usual ICU care. Cohort II, will enroll an additional 50 patients and randomize to receive either two physical therapy sessions per day or usual care. Outcome will be length of hospital stay measured in days. Secondary outcomes will be mortality, ventilator days, ICU days, and for Cohort II, grip strength, dynamometer strength assessments and the short physical performance battery (SPPB). Study subjects will have blood for cytokine analysis through their first week of study.
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
- Single (Outcomes Assessor)
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
- •Mechanically ventilated via an endotracheal tube or mask
排除标准
- •Inability to walk without assistance prior to acute ICU illness (use of a cane or walkers not exclusions)
- •Cognitive impairment prior to acute ICU illness (non-verbal)
- •Preadmit immunocompromised (>prednisone 20 mg/d for 2 wks)
- •Acute stroke
- •Body mass index (BMI) >45
- •Neuromuscular disease that could impair weaning (myasthenia gravis, ALS, Guillain-Barre)
- •Hip fracture, unstable cervical spine or pathological fracture
- •Mech vent >48 hours prior to transfer from an outside facility
- •Current hospitalization or transferring hospital stay >72 hours
- •CPR on admission, DNR on admission
- •Hospitalization within 30 days prior to admission
- •Cancer therapy within last 6 months
- •Re-admission to ICU within current hospitalization
研究组 & 干预措施
Usual Care
Usual hospital rehabilitative services
干预措施: Usual Care (Other)
Early ICU Rehabilitation Strategy
Early ICU physical therapy will be applied in this arm
干预措施: Early ICU rehabilitation strategies (Other)
结局指标
主要结局
Hospital length of stay, days
时间窗: The participants will be followed for the duration of the hospitalization, an expected average of 3 weeks.
Hospital stay measured in days.
次要结局
未报告次要终点