Functional Assessment in Critically Ill Patients

Recruiting

• Conditions: Intensive Care Unit Acquired Weakness; Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)

• Registration Number: NCT07191743
• Lead Sponsor: Universidade Federal do Rio de Janeiro

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.

Study Timeline

• Study Start: 2025-01-01
• Study First Submitted: 2025-08-26
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-25
• Last Update Posted: 2025-09-25
• Primary Completion: 2026-07-01
• Study Completion: 2027-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 186

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
hospital mortality	12 months	Mortality will be collected during the period of hospitalization

Secondary Outcome Measures

Name	Time	Method
mechanical ventilation days	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
Extubation rate	30 days	Proportion of patients who were extubated during ICU stay.
length of hospital	12 months	It will be collected from the date of intensive care unit admission until the outcome of hospital discharge or death.
ICU length of stay	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.
Reintubation rate	30 days	Proportion of patients who require reintubation after extubation during ICU stay.

Trial Locations

Locations (1)

Pedro Ernesto University Hospital; 🇧🇷 Rio de Janeiro, Rio de Janeiro, Brazil