Actively Recruiting

Age: 18Years +
All Genders
NCT07167121

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

Led by Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil · Updated on 2025-09-30

25

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 �3E= 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 �3E= 5 days;

  • Weight loss �3E= 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.

Not Eligible

You will not qualify if you...

  • 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).

AI-Screening

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Trial Site Locations

Total: 1 location

1

Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

Saint-Aubin-lès-Elbeuf, France, 76410

Actively Recruiting

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Research Team

A

Arthur SAUNIER, MKDE

CONTACT

P

Pierre HUNKELER

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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