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

NCT03619915 | Completed

• 1 other identifier: 436.770-1
• Study Type: observational
• Target: 197
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Intensive Care (ICU) Myopathy; Functional Independence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Functional Independence Measure (FIM)

  Three months after ICU discharge

Study Arms (3)

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

Interventions

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

Greater dependence; Independent; Less dependence

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.

Greater dependence; Independent; Less dependence

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Data will be collected from patients admitted to the ICU from January 2012 to December 2013.

You may qualify if:

• Patients who discharged alive evaluated three months after discharge from the ICU
• Patients that underwent spirometry and answer the Functional Independence Measure Questionnaire.

You may not qualify if:

• Patients unable to perform spirometry
• Patients unable to respond to the Functional Independence Measure questionnaire

Sponsors & Collaborators

• Universidade Estadual do Oeste do Paraná: lead

MeSH Terms

Conditions

Muscular Diseases

Interventions

Spirometry

Condition Hierarchy (Ancestors)

Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Clinical Professor of Department of Medicine, Western Parana State University Hospital

Study Record Dates

• First Submitted: July 20, 2018
• First Posted: August 8, 2018
• Study Start: January 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 13, 2018

Record last verified: 2018-08