Status:
RECRUITING
Predictive Validity of the Chelsea Critical Care Physical Assessment Tool (CPAx) for Regaining Autonomy Three Months After ICU Discharge
Lead Sponsor:
Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Conditions:
ICU Acquired Weakness
Intensive Care Neuropathy
Eligibility:
All Genders
18+ years
Brief 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 (...
Eligibility Criteria
Inclusion
- Patient affiliated with, or entitled to benefit from, a French social security system.
- Patient who has received clear and comprehensive information about the study and has signed the informed consent form together with the investigator.
- 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
- 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).
Key Trial Info
Start Date :
September 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT07167121
Start Date
September 1 2025
End Date
September 1 2026
Last Update
September 30 2025
Active Locations (1)
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1
Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Saint-Aubin-lès-Elbeuf, France, 76410