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NCT Number: NCT07191743

Functional Assessment in Critically Ill Patients

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pedro Ernesto University Hospital

Rio de Janeiro, 20551-030, Brazil

Location status: Recruiting

Location contact

Gabriel Gomes Maia, Doctorate

CONTACT

[email protected]

5521996267494

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. hospital mortality

    Time frame: 12 months

    Mortality will be collected during the period of hospitalization

Secondary outcomes

  1. mechanical ventilation days

    Time frame: 6 months

    It 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

  2. ICU length of stay

    Time frame: 6 months

    It will be collected from the date of intensive care unit admission until the outcome of discharge from the intensive care unit or death.

  3. length of hospital

    Time frame: 12 months

    It will be collected from the date of intensive care unit admission until the outcome of hospital discharge or death.

  4. Extubation rate

    Time frame: 30 days

    Proportion of patients who were extubated during ICU stay.

  5. Reintubation rate

    Time frame: 30 days

    Proportion of patients who require reintubation after extubation during ICU stay.

Study contacts

Contact information is provided by the study sponsor or research team.

GABRIEL G MAIA, PhD

CONTACT

[email protected]

+5521996267494

RAFAELA S PAIM

CONTACT

[email protected]

+5521988919158

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Collaborators

  • Hospital Universitario Pedro Ernesto
  • Instituto Nacional de Infectologia Evandro Chagas

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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