Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Saint-Aubin-lès-Elbeuf, 76410, France
NCT Number: NCT07167121
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Saint-Aubin-lès-Elbeuf, 76410, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
Time frame: Three months after discharge
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:
Time frame: Three months after discharge
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:
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.).
Centre Hospitalier Intercommunal Elbeuf-Louviers-Val de Reuil
Other Gov
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
Acronym: CPAx-Predict
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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