Study of Therapeutic Exercise in Acute Respiratory Failure to Improve Neuromuscular Disability Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,917
- 试验地点
- 8
- 主要终点
- Peak hour patient activity level
研究概览
简要总结
This is a stepped-wedge, cluster randomized, trial evaluating the effect of an early goal-directed mobilization intervention for ICU patients with acute respiratory failure within 12 medical and surgical ICUs across 4 hospitals in the University of Pennsylvania Health System. The investigators will conduct a 54-week trial to measure the effect of the intervention on multiple patient-centered outcomes of patient physical function and cognition, in addition to ICU and hospital length of stay and duration of mechanical ventilation compared to usual care.
详细描述
The STAND trial aims to measure the effect of an early goal-directed mobilization algorithm versus usual care for ICU patients with acute respiratory failure in the medical and surgical ICUs across University of Pennsylvania Health System (UPHS) with respect to patient-centered outcomes of patient physical function and cognition as well as multiple secondary clinical outcomes. To achieve this goal, the investigators will conduct a 54-week stepped-wedge, cluster randomized, trial to test the intervention during the course of providing usual care among a large and diverse population of patients admitted to 12 ICUs across 4 hospitals within UPHS. The intervention is an early mobilization protocol implemented during a patient's stay in the ICU. It involves three steps: 1) the clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door; 2) a facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts; 3) patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board. Approximately 1,500 adult patients with continuous mechanical ventilation for ≥48 hours (without interruption) and baseline independent ambulatory status will be enrolled. Participating ICUs will be randomized into 6 clusters of 2 ICUs each. Each ICU contributes a minimum of 12 weeks of data under the usual care control condition prior to implementing the early mobilization intervention. Then, using the stepped-wedge design, all ICUs will implement the intervention in 6-week intervals with the order and timing of implementation determined by random assignment. By the end of the trial, all ICUs will have utilized the intervention for at least 12 weeks. The primary outcome is peak patient activity level as measure by the ICU mobility score (IMS) at ICU discharge. Secondary outcomes include an array of clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, 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
- •Age ≥18 years old; AND
- •Admission to 1 of 12 participating ICUs; AND
- •Continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
- •Baseline independent ambulatory status
排除标准
- •Admitting diagnosis of any of the following conditions:
- •Cardiopulmonary arrest
- •Raised intracranial pressure
- •Acute neurological admission diagnosis
- •Subarachnoid hemorrhage
- •Ischemic stroke
结局指标
主要结局
Peak hour patient activity level
时间窗: Within 48 hours of ICU discharge
Peak hour patient activity level as measured by the ICU mobility score (IMS) at ICU discharge. IMS score ranges from 0 to 10.
次要结局
- ICU length of stay(From ICU admission to ICU discharge, approximately 3 days)
- Neurological function(From hospital admission to hospital discharge, approximately 5 days)
- Hospital length of stay(From hospital admission to hospital discharge, approximately 5 days)
- Richmond Agitation-Sedation Scale (RASS)(From hospital admission to hospital discharge, approximately 5 days)
- ICU mortality(From ICU admission to ICU discharge, approximately 3 days)
- Duration of mechanical ventilation(From hospital admission to hospital discharge, approximately 5 days)
- Duration of time spent in deep sedation(From hospital admission to hospital discharge, approximately 5 days)
研究者
Scott Halpern
Professor of Medicine
University of Pennsylvania