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OpenTrials
Completed

NCT Number: NCT03619915

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirometry

Diagnostic 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 Measure

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Functional Independence Measure (FIM)

    Time frame: Three months after ICU discharge

    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.

Sponsors and collaborators

Lead sponsor

Universidade Estadual do Oeste do Paraná

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 8, 2018
Registry last updated
Aug 13, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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