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Recruiting NCT07191743

Functional Assessment in Critically Ill Patients

Observational Intensive Care Unit Acquired Weakness Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Intensive Care Unit Acquired Weakness, Intensive Care Unit (ICU) Acquired Weakness (ICU - AW). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Brazil
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Assessment of Physical Function in Critically Ill Patients With the Chelsea Critical Care Assessment Tool (CPAX)

Overview

This longitudinal, prospective observational study aims to evaluate functional status in critically ill adult patients in the Intensive Care Unit using the Chelsea Critical Care Physical Assessment Tool (CPAx). The primary objective is to analyze CPAx score variation as a potential predictor of clinical outcomes, including mortality and duration of mechanical ventilation. Functional assessments will be performed at intensive care unit (ICU) admission and discharge to monitor changes in physical function and to predict adverse clinical outcomes.

Detailed description

This prospective, longitudinal, and observational study will be conducted at the general ICU of Pedro Ernesto University Hospital (HUPE). Demographic and clinical information at admission will be collected, including age, sex, type of airway at ICU admission, cause of ICU admission, comorbidities, and clinical scores such as Sepsis-related Organ Failure Assessment (SOFA), Simplified Acute Physiology Score III (SAPS III), and Charlson Comorbidity Index. During the ICU stay, data on the use of invasive mechanical ventilation, non-invasive ventilation, high-flow nasal cannula (HFNC), renal replacement therapy, extubation, and reintubation will be recorded. The CPAx will be assessed at ICU admission and discharge. Additionally, total hospital and ICU length of stay, as well as days on mechanical ventilation, will be recorded.The study aims to analyze the variation in CPAx scores as a predictor of adverse clinical outcomes, including mortality and duration of mechanical ventilation.

Primary outcome measures

  • hospital mortality [Time frame: 12 months]
Secondary outcome measures (5)
  • mechanical ventilation days [Time frame: 6 months]
  • ICU length of stay [Time frame: 6 months]
  • length of hospital [Time frame: 12 months]
  • Extubation rate [Time frame: 30 days]
  • Reintubation rate [Time frame: 30 days]

Eligibility criteria

Inclusion Criteria: All adult patients admitted to the Pedro Ernesto University Hospital (HUPE) General ICU over 18 years of age and with an ICU stay greater than or equal to 48 hours will be included.

Exclusion criteria

  • Pregnancy
  • Inability to record the CPAx score within the first 48 hours of ICU admission or on the day of ICU discharge
  • ICU readmission
  • Known comorbidities causing generalized weakness, such as neuromuscular or neurological diseases

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Brazil · 1 center
  • Pedro Ernesto University Hospital — Rio de Janeiro

Identifiers

NCT: NCT07191743 · 65516422.7.0000.5259

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗