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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial population

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 (icuaw), or post-traumatic stress symptoms

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CPAx

    Diagnostic test

    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)

Treatment groups

25 Participants
are divided into 1 treatment group
Group A: Interventional Group1 intervention

Trial outcomes

Primary outcomes

1

Predictive validity beetween CPAx test and 6MWT

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.

Time frame
Three months after discharge

Secondary outcomes

1

Correlation between CPAx and SF-36 questionnary

Analysis of the correlation between each item of the CPAx and the results of the 6-minute walk test three months after ICU discharge. Analysis of the correlation between individual CPAx item scores and SF-36 questionnaire results three months after ICU discharge Methods for Secondary Outcomes: * Correlation between CPAx items and 6MWT: Each CPAx item will be analyzed individually as a discrete ordinal variable. Spearman's correlation will be used. * Correlation between overall CPAx score and SF-36 dimensions: These correlations will be assessed using Spearman's test, unless normality of SF-36 subscales is confirmed. Exploratory analyses using simple or multiple linear regression may also be conducted to model the relationship between CPAx and 6MWT, adjusting for clinical variables (age, BMI, duration of ventilation, etc.).

Time frame
Three months after discharge

Other outcomes

Sponsors and contacts

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