Intensive Care (ICU) MyopathyNCT03619915
Correlation Between Spirometry and Functional Independence in Adult Post-ICU Patients
An observational study of Intensive Care (ICU) Myopathy and Functional Independence, run by Universidade Estadual do Oeste do Paraná.
Trial summary
Several complications and comorbidities are frequently found in patients admitted to an Intensive Care Unit (ICU), including acquired ICU muscle weakness and physical and cognitive limitations. These issues lead to impaired quality of life and post-discharge functional independence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care (ICU) Myopathy, Functional Independence
- What is being tested?
- Spirometry and Functional Independence Measure
- How many people
- 197 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Data will be collected from patients admitted to the ICU from January 2012 to December 2013.
Who may be able to join
- Patients who discharged alive evaluated three months after discharge from the ICU
- Patients that underwent spirometry and answer the Functional Independence Measure Questionnaire.
Who cannot join
- Patients unable to perform spirometry
- Patients unable to respond to the Functional Independence Measure questionnaire
About this study
Several complications and comorbidities are frequently found in patients admitted to an Intensive Care Unit (ICU), including acquired ICU muscle weakness and physical and cognitive limitations. These issues lead to impaired quality of life and post-discharge functional independence. Thus, it is important to evaluate these factors in order to verify the effects of long-term hospitalization. Objective: To relate functional independence to the degree of pulmonary involvement in adult patients three months after discharge from the ICU. Methods: This will be a retrospective study with data collected from January 2012 to December 2013, that will include patients who underwent spirometry and answered the Functional Independence Measure Questionnaire. Patients will be divided into groups according to the classification of functional independence and spirometry.
- Being tested
- Spirometry, Functional Independence Measure
- Medical subject headings
- Muscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpirometryDiagnostic test
The test will follow the norms of the American Thoracic Society and reference values relative to the Brazilian population. The tests will be performed by physical therapists using the One Flow FVC® portable spirometer (Clement Clarke, England) and met the criteria for acceptance and reproduction of manoeuvres
Functional Independence MeasureOther
Will be used to evaluate the functional independence of patients containing eighteen items encompassing six dimensions. Each item can receive scores of one to seven, where one corresponds to total dependency and seven to full independence. Each dimension is analysed by the sum of the items that compose it and the total score is given by the sum of each dimension, being able to vary from 18: complete dependence; 19 to 60: greater dependence (assistance of up to 50% of tasks); 61 to 103: less dependency (assistance of up to 25% of tasks); and 104 to 126: independent.
| Study group | Role | What they receive |
|---|---|---|
| Greater dependence | Not described Receives: Diagnostic Test: Spirometry; Other: Functional Independence Measure | |
| Less dependence | Not described Receives: Diagnostic Test: Spirometry; Other: Functional Independence Measure | |
| Independent | Not described Receives: Diagnostic Test: Spirometry; Other: Functional Independence Measure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spirometry
The spirometry will follow the norms of the American Thoracic Society and reference values relative to the Brazilian population. The tests will be performed by physical therapists using the One Flow FVC® portable spirometer (Clement Clarke, England) and met the criteria for acceptance and reproduction of manoeuvres.
Measured: Three months after ICU discharge
Secondary outcomes (1)
Functional Independence Measure (FIM)
FIM will be use to evaluate the functional independence of patients containing eighteen items encompassing six dimensions. Each item can receive scores of one to seven, where one corresponds to total dependency and seven to full independence. Each dimension is analysed by the sum of the items that compose it and the total FIM score is given by the sum of each dimension, being able to vary from 18: complete dependence; 19 to 60: greater dependence (assistance of up to 50% of tasks); 61 to 103: less dependency (assistance of up to 25% of tasks); and 104 to 126: independent.
Measured: Three months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study startJan 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care (ICU) MyopathyStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual do Oeste do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pericles Almeida Delfino Duarte, Universidade Estadual do Oeste do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619915
- Sponsor's protocol ID
- 436.770-1
- Status last verified
- Aug 2018
- First submitted
- 20 Jul 2018
- Last updated
- 13 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Spirometry and Functional Independence in Adult Post-ICU Patients
- ClinicalTrials.gov ID
- NCT03619915
- Acronym / sponsor ID
- 436.770-1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Universidade Estadual do Oeste do ParanáUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 8 Aug 2018 (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.
Several complications and comorbidities are frequently found in patients admitted to an Intensive Care Unit (ICU), including acquired ICU muscle weakness and physical and cognitive limitations. These issues lead to impaired quality of life and post-discharge functional independence. Thus, it is important to evaluate these factors in order to verify the effects of long-term hospitalization. Objective: To relate functional independence to the degree of pulmonary involvement in adult patients three months after discharge from the ICU. Methods: This will be a retrospective study with data collected from January 2012 to December 2013, that will include patients who underwent spirometry and answered the Functional Independence Measure Questionnaire. Patients will be divided into groups according to the classification of functional independence and spirometry.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Greater dependence | – | Diagnostic Test: Spirometry, Other: Functional Independence Measure |
| Less dependence | – | Diagnostic Test: Spirometry, Other: Functional Independence Measure |
| Independent | – | Diagnostic Test: Spirometry, Other: Functional Independence Measure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Data will be collected from patients admitted to the ICU from January 2012 to December 2013.
Key inclusion criteria (2 listed)
- Patients who discharged alive evaluated three months after discharge from the ICU
- Patients that underwent spirometry and answer the Functional Independence Measure Questionnaire.
Key exclusion criteria (2 listed)
- Patients unable to perform spirometry
- Patients unable to respond to the Functional Independence Measure questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SpirometryThe test will follow the norms of the American Thoracic Society and reference values relative to the Brazilian population. The tests will be performed by physical therapists using the One Flow FVC® portable spirometer (Clement Clarke, England) and met the criteria for acceptance and reproduction of manoeuvres | Diagnostic test | Greater dependence, Independent, Less dependence |
| Functional Independence MeasureWill be used to evaluate the functional independence of patients containing eighteen items encompassing six dimensions. Each item can receive scores of one to seven, where one corresponds to total dependency and seven to full independence. Each dimension is analysed by the sum of the items that compose it and the total score is given by the sum of each dimension, being able to vary from 18: complete dependence; 19 to 60: greater dependence (assistance of up to 50% of tasks); 61 to 103: less dependency (assistance of up to 25% of tasks); and 104 to 126: independent. | Other | Greater dependence, Independent, Less dependence |
Primary outcome
Spirometry
Time frame: Three months after ICU discharge
The spirometry will follow the norms of the American Thoracic Society and reference values relative to the Brazilian population. The tests will be performed by physical therapists using the One Flow FVC® portable spirometer (Clement Clarke, England) and met the criteria for acceptance and reproduction of manoeuvres.
1 secondary outcome
Functional Independence Measure (FIM)
Time frame: Three months after ICU discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2018.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care (ICU) Myopathy and Functional Independence, run by Universidade Estadual do Oeste do Paraná.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 13 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spirometry (time frame: Three months after ICU discharge). 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 13 Aug 2018.