Intensive Care Unit Acquired WeaknessNCT07191743
Functional Assessment in Critically Ill Patients
An observational study of Intensive Care Unit Acquired Weakness and Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Unit Acquired Weakness, Intensive Care Unit (ICU) Acquired Weakness (ICU - AW)
- How many people
- 186 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Jan 2025to 1 Dec 2027
- How long will I take part?
- 10 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Pedro Ernesto University Hospital
Rio de Janeiro, Rio de Janeiro, 20551-030
Gabriel Gomes Maia, Doctorate, 5521996267494, gmaiafisio@gmail.com
About this study
Official title: Assessment of Physical Function in Critically Ill Patients With the Chelsea Critical Care Assessment Tool (CPAX)
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.
- 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
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
hospital mortality
Mortality will be collected during the period of hospitalization
Measured: 12 months
Secondary outcomes (5)
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
Measured: 6 months
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.
Measured: 6 months
length of hospital
It will be collected from the date of intensive care unit admission until the outcome of hospital discharge or death.
Measured: 12 months
Extubation rate
Proportion of patients who were extubated during ICU stay.
Measured: 30 days
Reintubation rate
Proportion of patients who require reintubation after extubation during ICU stay.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2025
- Study start1 Jan 2025
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit Acquired WeaknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 186 participants (estimated)
- Target duration
- 10 Days
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Pedro Ernesto, Instituto Nacional de Infectologia Evandro Chagas
- Responsible party
- Principal investigator, Jose Roberto Lapa e Silva, Universidade Federal do Rio de Janeiro
- Investigators
- PEDRO L SILVA, PhD, Study director, Pulmonary Investigation Laboratory, Carlos Chagas Filho Institute of Biophysics (IBCCF), Federal University of Rio de Janeiro (UFRJ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07191743
- Sponsor's protocol ID
- 65516422.7.0000.5259
- Status last verified
- Sep 2025
- First submitted
- 26 Aug 2025
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Physical Function in Critically Ill Patients With the Chelsea Critical Care Assessment Tool (CPAX)
- ClinicalTrials.gov ID
- NCT07191743
- Acronym / sponsor ID
- 65516422.7.0000.5259
- 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
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Collaborators
- Hospital Universitario Pedro Ernesto, Instituto Nacional de Infectologia Evandro Chagas
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 25 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
hospital mortality
Time frame: 12 months
Mortality will be collected during the period of hospitalization
5 secondary outcomes
mechanical ventilation days
Time frame: 6 months
ICU length of stay
Time frame: 6 months
length of hospital
Time frame: 12 months
Extubation rate
Time frame: 30 days
Reintubation rate
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
PEDRO L SILVA, PhD study director
Pulmonary Investigation Laboratory, Carlos Chagas Filho Institute of Biophysics (IBCCF), Federal University of Rio de Janeiro (UFRJ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Acquired Weakness and Intensive Care Unit (ICU) Acquired Weakness (ICU - AW), run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RAFAELA S PAIM (+5521988919158, rafaeladspaim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hospital mortality (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.