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RECRUITING

NCT07167121

Predictive Validity of the Chelsea Critical Care Physical Assessment Tool (CPAx) for Regaining Autonomy Three Months After ICU Discharge

Sponsor: Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2025-09-01

Completion Date

2026-09-01

Last Updated

2025-09-30

Healthy Volunteers

Conditions

ICU Acquired Weakness Intensive Care Neuropathy

Interventions

DIAGNOSTIC_TEST

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)

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 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 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).

Locations (1)

Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

Saint-Aubin-lès-Elbeuf, France