Etude de validité Predictive du Chelsea Critical Care Physical Assessment Tool (CPAx) Quant au Retour de l'Autonomie à la Marche 3 Mois après la Sortie de réanimation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Predictive validity beetween CPAx test and 6MWT
研究概览
简要总结
This single-center observational study aims to explore the relationship between the CPAx score (Chelsea Critical Care Physical Assessment Tool), measured at ICU discharge, and the 6-minute walk test (6MWT) distance performed 3 months after discharge. The study targets patients who experienced prolonged mechanical ventilation and were admitted to the ICU at CHI Elbeuf-Louviers-Val-de-Reuil. Eligible participants must show signs of malnutrition, muscular weakness, or post-traumatic stress symptoms. Data collection includes the CPAx score, 6MWT distance, MRC score, and relevant clinical and demographic information. The primary objective is to determine whether the CPAx score can predict long-term functional recovery and guide post-ICU rehabilitation strategies. Participants will be evaluated during routine follow-up in the day hospital. This non-interventional study poses minimal risk to participants.
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
- •Patient affiliated with, or entitled to benefit from, a French social security system.
- •Patient who has received clear and comprehensive information about the study
- •Age ≥ 18 years.
- •Having received at least 48 hours of invasive mechanical ventilation.
- •Previous hospitalization in the intensive care unit (ICU) at CHI Elbeuf-Louviers-Val-de-Reuil.
- •Prescription of physiotherapy during the ICU stay.
- •Eligible for the 3-month post-ICU follow-up in the day hospital based on at least one of the following criteria:
- •Mechanical ventilation or catecholamine treatment (norepinephrine) for ≥ 5 days;
- •Weight loss ≥ 5% during hospitalization (criterion for malnutrition);
- •Significant muscle weakness (MRC score < 28/60);
- •Presence of post-traumatic stress symptoms related to ICU stay (evaluated by the psychologist).
- •Ability to walk (with or without assistive devices) prior to ICU admission.
排除标准
- •Patient not affiliated with the French national health insurance system.
- •Documented pre-existing cognitive impairment likely to limit understanding of instructions and participation in functional assessments (e.g., dementia, intellectual disability, severe uncontrolled psychiatric disorder).
- •History of disabling chronic neuromuscular disease (e.g., amyotrophic lateral sclerosis, myopathy, progressive chronic polyneuropathy).
- •History of major pre-existing locomotor impairment preventing autonomous walking (e.g., paraplegia, uncompensated disabling arthropathy).
- •Refusal to participate in the study or withdrawal of consent at any time.
- •Person under legal guardianship, curatorship, or any other legal protection measure.
- •Simultaneous participation in another interventional study likely to interfere with the evaluation criteria of the present study.
- •Medical contraindication to performing the 6-minute walk test at 3 months (e.g., cardiovascular decompensation, acute pulmonary disease, persistent hemodynamic instability).
研究组 & 干预措施
Interventional Group
Assessment of the CPAx score at ICU discharge, followed by the 6-minute walk test three months after ICU Discarge.
干预措施: CPAx (Diagnostic Test)
结局指标
主要结局
Predictive validity beetween CPAx test and 6MWT
时间窗: Three months after discharge
Evaluation Criteria: The statistical analysis will primarily aim to assess the correlation between the CPAx score, a discrete quantitative variable (ranging from 0 to 50), and the distance covered in the 6-Minute Walk Test (6MWT), a continuous quantitative variable. The alpha risk is set at 5% and the beta risk at 80%. A sample size of 25 patients has been determined to allow for an initial estimate, accounting for an anticipated 20% loss to follow-up, in line with recommendations for feasibility studies in intensive care settings. Method : The choice of correlation test will depend on data distribution: * If CPAx and 6MWT distributions are normal (as verified by Shapiro-Wilk or Kolmogorov-Smirnov tests), Pearson's correlation will be used. * In the absence of normality or in the presence of significant skewness, Spearman's correlation (a non-parametric test) will be preferred.
次要结局
- Correlation between CPAx and SF-36 questionnary(Three months after discharge)