Predictive Validity of the Chelsea Critical Care Physical Assessment Tool (CPAx) for Regaining Au… (NCT07167121) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Predictive Validity of the Chelsea Critical Care Physical Assessment Tool (CPAx) for Regaining Autonomy Three Months After ICU Discharge
France25 participantsStarted 2025-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Predictive validity beetween CPAx test and 6MWT
Timeframe: Three months after discharge
Trial details
NCT IDNCT07167121
SponsorCentre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil