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Recruiting NCT07167121

NCT07167121 Predictive Validity of the Chelsea Critical Care Physical Assessment Tool (CPAx) for Regaining Autonomy Three Months After ICU Discharge

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Clinical Trial Summary
NCT ID NCT07167121
Status Recruiting
Phase
Sponsor Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Condition ICU Acquired Weakness
Study Type OBSERVATIONAL
Enrollment 25 participants
Start Date 2025-09-01
Primary Completion 2026-08-01

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age N/A
Study Type OBSERVATIONAL
Interventions
CPAx

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 25 participants in total. It began in 2025-09-01 with a primary completion date of 2026-08-01.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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.

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).

Contact & Investigator

Central Contact

Arthur SAUNIER, MKDE

✉ arthur.saunier@chi-elbeuf-louviers.fr

📞 0232962296

Frequently Asked Questions

Who can join the NCT07167121 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, studying ICU Acquired Weakness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07167121 currently recruiting?

Yes, NCT07167121 is actively recruiting participants. Contact the research team at arthur.saunier@chi-elbeuf-louviers.fr for enrollment information.

Where is the NCT07167121 trial being conducted?

This trial is being conducted at Saint-Aubin-lès-Elbeuf, France.

Who is sponsoring the NCT07167121 clinical trial?

NCT07167121 is sponsored by Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil. The trial plans to enroll 25 participants.

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