Functional Assessment in Critically Ill Patients

NCT07191743 | Recruiting

• 1 other identifier: 65516422.7.0000.5259
• Study Type: observational
• Target: 186
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• hospital mortality

  Mortality will be collected during the period of hospitalization

  12 months

Secondary Outcomes (5)

• mechanical ventilation days

  6 months

• ICU length of stay

  6 months

• length of hospital

  12 months

• Extubation rate

  30 days

• Reintubation rate

  30 days

Study Arms (2)

Survivors

Adult patients admitted to the general ICU at Pedro Ernesto University Hospital (HUPE) who were discharged from the ICU to the hospital ward.

Non-Survivors

Adult patients admitted to the general ICU at Pedro Ernesto University Hospital (HUPE) who died during their ICU stay.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The general ICU admits both surgical patients and clinical patients, including those with acute illnesses or decompensations of chronic diseases. Participants include both male and female patients.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead
• Hospital Universitario Pedro Ernesto: collaborator
• Instituto Nacional de Infectologia Evandro Chagas: collaborator

Study Sites (1)

Pedro Ernesto University Hospital

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

RECRUITING

MeSH Terms

Conditions

Muscle Weakness

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• PEDRO L SILVA, PhD

  Pulmonary Investigation Laboratory, Carlos Chagas Filho Institute of Biophysics (IBCCF), Federal University of Rio de Janeiro (UFRJ)

  STUDY DIRECTOR

Central Study Contacts

RAFAELA S PAIM

CONTACT

+5521988919158; rafaeladspaim@gmail.com

GABRIEL G MAIA, PhD

CONTACT

+5521996267494; gmaiafisio@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Pneumology

Study Record Dates

• First Submitted: August 26, 2025
• First Posted: September 25, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)