Responsiveness and the Minimal Clinically Important Difference of the Chelsea Critical Care Physical Assessment Tool (CPAx) in Critically Ill, Mechanically Ventilated Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Chelsea Critical Care Physical Assessment tool (CPAx) change score
研究概览
简要总结
Intensive care unit (ICU) acquired weakness is a common complication associated with long-term physical impairments in survivors of a critical illness. The Chelsea Critical Care Physical Assessment tool (CPAx) is a valid and reliable instrument for physical function and activity in critically ill patients at risk for muscle weakness. However, its ability to measure change over time (responsiveness) and the minimal clinically important difference (MCID) have not yet been rigorously investigated. This multi-centre, mixed-methods, longitudinal cohort study therefore aims to establish responsiveness and the MCID of the CPAx in the target population from ICU baseline to ICU and hospital discharge. The study uses routine data from standard physiotherapy sessions like mobility, function and activity with no additional burden for critically ill adults. The investigators expect the CPAx to be responsive allowing its use as a primary outcome in future effectiveness trials for the treatment of ICU-acquired weakness using the newly established MCID for sample size calculation. A high quality, rigorously tested measurement tool for physical function and activity in the ICU should benefit researchers, clinicians and patients.
详细描述
The use of invasive life support in critically ill patients clearly saves lives but carries substantial risks, including intensive care unit (ICU) acquired weakness and long-term disability. The investigators urgently need a valid, reliable, and responsive measurement tool for this population to use in clinical practice and trials. The Chelsea Critical Care Physical Assessment tool (CPAx) is a promising measurement instrument to measure change in critically ill patients' physical function and activity. After several studies have confirmed its validity and excellent reliability, it is time to confirm responsiveness and to establish the MCID in a large, international sample of the target population. This multi-centre, mixed-methods, longitudinal cohort study will include critically ill, mechanically ventilated (>72h) adults at risk for muscle weakness and collect their mobility, physical function and activity with the CPAx and other relevant measures at ICU baseline, to ICU and hospital discharge. Responsiveness will be determined by the ability of the CPAx to identify change according to a prespecified anchor (criterion validity) and by testing prospective hypotheses about the expected magnitude of change between the CPAx and other relevant measures (construct validity). The MCID will be established with anchor- and distribution-based methods, whereby a seven-point global rating of change scale obtained from treating ICU physiotherapists will serve as anchor to distinguish improved from unchanged patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Mechanical ventilation ≥ 72 hours
- •Expected to remain for ≥ 48 hours in the ICU
- •Physiotherapy referral
排除标准
- •Not expected to survive to hospital discharge (imminent to death)
- •Second or subsequent ICU admission for this hospital stay
- •Transfer from external ICU (with an ICU stay of >72 hours)
- •Primary neurological admission diagnosis (i.e., of the central nervous system including stroke, intracerebral haemorrhage, traumatic brain injury)
- •Known pregnancy
- •Living in a care facility pre-admission (severe pre-existing mental or physical disability)
- •Local regulations (i.e. Switzerland: refusal of general consent)
结局指标
主要结局
Chelsea Critical Care Physical Assessment tool (CPAx) change score
时间窗: Assessed at ICU discharge (within 24 hours before or after ICU discharge)
CPAx change score for ICU period (ICU baseline to ICU discharge); CPAx ranges from 0 (worst score) to 50 (best score)
次要结局
- Medical Research Council Sum Score(ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge)
- Modified Iowa Level of Assistance Scale(ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge)
- CPAx change score(Assessed at hospital discharge (last value before discharge))
- Global rating of change scale(ICU and hospital discharge (change for ICU and hospital period))
- Richmond Agitation-Sedation Scale(ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge)
- ICU Mobility Scale(ICU baseline (within 72-144h after ICU admission), ICU and hospital discharge)
- ICU and discharge destinations(ICU and hospital discharge)