Correlation Between Spirometry and Functional Independence in Adult Post-ICU Patients

Intensive Care (ICU) Myopathy Clinical Trial

Official title:

Correlation Between Spirometry and Functional Independence in Adult Post-ICU Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03619915
• Other study ID #: 436.770-1
• Status: Completed
• Start date: January 2012
• Est. completion date: December 2013

Study information

• Verified date: August 2018
• Source: Universidade Estadual do Oeste do Paraná
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who discharged alive evaluated three months after discharge from the ICU

• Patients that underwent spirometry and answer the Functional Independence Measure Questionnaire.

Exclusion Criteria:

• Patients unable to perform spirometry

• Patients unable to respond to the Functional Independence Measure questionnaire

Related Conditions & MeSH terms

• Functional Independence
• Intensive Care (ICU) Myopathy

Intervention

Diagnostic Test:
• Spirometry
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

Other:
• Functional Independence Measure
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Estadual do Oeste do Paraná

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Three months after ICU discharge
Secondary	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.	Three months after ICU discharge