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

C

Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

Status

Enrolling

Conditions

Intensive Care Neuropathy
ICU Acquired Weakness

Treatments

Diagnostic Test: CPAx

Study type

Observational

Funder types

Other

Identifiers

NCT07167121
2025-A01335-44

Details and patient eligibility

About

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.

Enrollment

25 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

25 participants in 1 patient group

Interventional Group
Description:
Assessment of the CPAx score at ICU discharge, followed by the 6-minute walk test three months after ICU Discarge.
Treatment:
Diagnostic Test: CPAx

Trial contacts and locations

1

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Central trial contact

Pierre HUNKELER; Arthur SAUNIER, MKDE

Data sourced from clinicaltrials.gov

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