Functional Assessment in Critically Ill Patients

NCT ID: NCT07191743

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

186 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-01-01

Study Completion Date

2027-12-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Survivors

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

No interventions assigned to this group

Non-Survivors

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role collaborator

Instituto Nacional de Infectologia Evandro Chagas

UNKNOWN

Sponsor Role collaborator

Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Jose Roberto Lapa e Silva

Full Professor of Pneumology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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PEDRO L SILVA, PhD

Role: STUDY_DIRECTOR

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

Locations

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Pedro Ernesto University Hospital

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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RAFAELA S PAIM

Role: CONTACT

+5521988919158

GABRIEL G MAIA, PhD

Role: CONTACT

+5521996267494

Facility Contacts

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Gabriel Gomes Maia, Doctorate

Role: primary

5521996267494

Other Identifiers

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65516422.7.0000.5259

Identifier Type: -

Identifier Source: org_study_id

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