Using the CPAx score at ICU discharge to predict regaining independence three months later

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

This study will see if the CPAx score taken when you leave the ICU can help predict how far adults who needed prolonged mechanical ventilation will be able to walk three months later.

Quick facts

• Study type: Observational
• Enrollment: 25 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil (Government)
• Locations: 1 site (Saint-Aubin-lès-Elbeuf)
• Trial ID: NCT07167121 on ClinicalTrials.gov

What this trial studies

This single-center observational study will record CPAx scores at ICU discharge and compare them with the six-minute walk test (6MWT) distance measured at a three-month routine follow-up. Eligible adults previously admitted to the ICU at CHI Elbeuf-Louviers-Val-de-Reuil who had at least 48 hours of invasive ventilation and signs of malnutrition, muscle weakness, or post‑traumatic stress will be included. Data collected will also include MRC scores and relevant clinical and demographic information to adjust analyses. The study is non-interventional and embedded in routine day-hospital follow-up, posing minimal additional risk to participants.

Who should consider this trial

Good fit: Adults (≥18) previously hospitalized in the ICU at CHI Elbeuf-Louviers-Val-de-Reuil who had ≥48 hours of invasive mechanical ventilation, a prescription for physiotherapy in ICU, meet at least one follow-up eligibility criterion (≥5 days ventilation/catecholamines, ≥5% weight loss, MRC <28, or PTSD symptoms), were ambulatory before ICU, consent, and are covered by the French social security system.

Not a fit: Patients who had short ICU stays or brief ventilation, who lack signs of malnutrition or weakness, who cannot attend the three-month follow-up in person, or who have preexisting severe mobility limitations are unlikely to benefit from the predictive information this study seeks.

Why it matters

Potential benefit: If successful, the CPAx could help clinicians identify ICU survivors who need more intensive or earlier rehabilitation to improve longer-term walking ability and independence.

How similar studies have performed: Previous work has shown CPAx relates to early functional outcomes after ICU, but using CPAx specifically to predict three-month 6MWT distance is less well established and relatively novel.

Eligibility criteria

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).

Where this trial is running

Saint-Aubin-lès-Elbeuf

• Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil — Saint-Aubin-lès-Elbeuf, France (Recruiting)

Study contacts

• Study coordinator: Arthur SAUNIER, MKDE

Conditions ICU Acquired Weakness; Intensive Care Neuropathy; ICU; Physiotherapy; CPAx; Predictive Validity; Test