Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Phase
Observational
Started
2025-09-01
Last updated
2026-09-02
Condition(s) studied
ICU Acquired WeaknessIntensive Care Neuropathy
Investigational drug(s) / intervention(s)
CPAx
CPAx: Evaluation of :
Respiratory function Cough Moving within the bed Supine to sitting on the edge of the bed Dynamic sitting Standing balance Sit to stand (starting position ≥ 90°) Transfering from bed to chair Stepping Grip strength (predicted mean for age and gender on the strongest hand)
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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).
Primary outcome measure(s)
Predictive validity beetween CPAx test and 6MWT — 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.
Trial sites (1)
Facility
City
Region
Status
Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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