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Functional Assessment in Critically Ill Patients

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07191743
Enrollment
186
Registered
2025-09-25
Start date
2025-01-01
Completion date
2027-12-01
Last updated
2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Critical Care, Intensive Care Units, Physical Therapy Department, Hospital, Muscle Weakness, Functional Status, Physical Functional Performance, Outcome Assessment, Health Care, Rehabilitation

Brief summary

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.

Interventions

None listed

Sponsors

Hospital Universitario Pedro Ernesto
CollaboratorOTHER
Instituto Nacional de Infectologia Evandro Chagas
CollaboratorUNKNOWN
Universidade Federal do Rio de Janeiro
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
hospital mortality12 monthsMortality will be collected during the period of hospitalization

Secondary

MeasureTime frameDescription
mechanical ventilation days6 monthsIt will be collected from the date of intubation in the intensive care unit until the date of extubation or up to 48 hours off mechanical ventilation in cases of tracheostomized patients and/or until the outcome of death
ICU length of stay6 monthsIt will be collected from the date of intensive care unit admission until the outcome of discharge from the intensive care unit or death.
length of hospital12 monthsIt will be collected from the date of intensive care unit admission until the outcome of hospital discharge or death.
Extubation rate30 daysProportion of patients who were extubated during ICU stay.
Reintubation rate30 daysProportion of patients who require reintubation after extubation during ICU stay.

Countries

Brazil

Contacts

Primary ContactRAFAELA S PAIM
rafaeladspaim@gmail.com+5521988919158
Backup ContactGABRIEL G MAIA, PhD
gmaiafisio@gmail.com+5521996267494

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026