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RecruitingNCT07191743Updated Sep 25, 2025

Functional Assessment in Critically Ill Patients

An observational study in Intensive Care Unit Acquired Weakness and Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), sponsored by Universidade Federal do Rio de Janeiro. Recruiting at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.

Sponsored by Universidade Federal do Rio de Janeiro · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2026, 4 months ago, but the record still lists the study as recruiting.
  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
186
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • Critical Care
  • Intensive Care Units
  • Physical Therapy Department, Hospital
  • Muscle Weakness
  • Functional Status
  • Physical Functional Performance
  • Outcome Assessment, Health Care
  • Rehabilitation
03

In context

Muscle Weakness

477 studies on the registry are indexed under Muscle Weakness; 73 are open to participants now.

This study's planned enrollment of 186 is above the median of 68 across 108 observational studies indexed under Muscle Weakness.

Browse Muscle Weakness studies →

Lead sponsor

Universidade Federal do Rio de Janeiro is the lead sponsor of 123 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Eligibility criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
186 participants (estimated)
Target follow-up
10 Days
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. hospital mortality

    Mortality will be collected during the period of hospitalization

    Time frame: 12 months

Secondary outcomes

  1. mechanical ventilation days

    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

    Time frame: 6 months

  2. ICU length of stay

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

    Time frame: 6 months

  3. length of hospital

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

    Time frame: 12 months

  4. Extubation rate

    Proportion of patients who were extubated during ICU stay.

    Time frame: 30 days

  5. Reintubation rate

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

    Time frame: 30 days

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jul 2026, 18 months after the start.

Of 48 non-industry observational studies under Muscle Weakness, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 63. This study's planned 18 months is below that.

Counting every sponsor, half of 50 studies reached it within 26 months; a quarter within 12 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 26, 2025
First posted
Sep 25, 2025
StartActual
Jan 1, 2025
Primary completionEst.
Jul 1, 2026
CompletionEst.
Dec 1, 2027
Last update
Sep 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07191743
Collaborators
Hospital Universitario Pedro Ernesto, Instituto Nacional de Infectologia Evandro Chagas
Responsible party
Jose Roberto Lapa e Silva (Full Professor of Pneumology, Universidade Federal do Rio de Janeiro) — Principal investigator
First posted
Sep 25, 2025
Start date
Jan 1, 2025
Primary completion
Jul 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 25, 2025

Study contacts

RAFAELA S PAIM
Contact
rafaeladspaim@gmail.com
+5521988919158
GABRIEL G MAIA, PhD
Contact
gmaiafisio@gmail.com
+5521996267494
PEDRO L SILVA, PhD
study director · Pulmonary Investigation Laboratory, Carlos Chagas Filho Institute of Biophysics (IBCCF), Federal University of Rio de Janeiro (UFRJ)

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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