Complexity of the Airflow in COPD

NCT ID: NCT01888705

Last Updated: 2013-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-12-31

Brief Summary

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Recently, there has been a growing interest in the study of nonlinear dynamics as a methodology for complementary analysis to characterize the respiratory pattern. These methods are well established in studies of heart rate. The analyzes evaluate complex signals, including large-scale fractal correlations and distributions in time series, and can provide relevant clinical information.

Measures such as approximate entropy and sample entropy have shown great potential in the evaluation of the complexity of the respiratory system, providing information relevant to the understanding of physiological and pathophysiological processes. These measures are based on the concept of non-linearity in the presence of a high number of interconnections, resulting in the complex behavior exhibited by physiological systems.

The approximate entropy (ApEn) is related to the amount of clutter, complexity or unpredictability of a data series over time. In a complementary way, the sample entropy (SampEn), is a far more elaborate than the ApEn, to reduce possible biased estimates due to self-similarity.

A study conducted by our group in asthma patients with different levels of bronchial obstruction demonstrated a significant reduction in airflow approximate entropy (ApEnV´) in asthmatic subjects. Investigators believe that in COPD, similar to that which occurs in asthma disorders that are associated with complex changes in the pathophysiology triggering breath control, possibly resulting in changes in air flow (V´).

Considering the development "silent" changes of mechanical ventilation in COPD patients and its clinical relevance, as well as the difficulty of identifying such changes through conventional methods, we observed the need to obtain more detailed information, including the complexity of the system breathing for better understanding of factors that contribute to the illness.

In this context, the objectives of this study were: (1) analyze the influence of airway obstruction in the complexity of the patterns of airflow in patients with COPD, (2) evaluate the diagnostic power of the test in identifying the changes caused by COPD.

Detailed Description

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Conditions

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COPD

Keywords

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COPD Complexity Entropy Sampling Variability Respiratory Mechanics FOT

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control group

Group of nonsmokers individuals without respiratory disease.

No interventions assigned to this group

NE

Smokers wiht normal spirometry.

No interventions assigned to this group

LV

Patients with COPD level I, mild.

No interventions assigned to this group

MOD

Patients with COPD level II, moderate.

No interventions assigned to this group

GV

Patients with COPD level III, severe.

No interventions assigned to this group

MGV

Patients with COPD level IV, very severe.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* volunteers with COPD for Patients Group;
* volunteers without any respiratory disease for the control group.

Exclusion Criteria

* individuals with history of tuberculosis or other lung disease,
* heart disease in general and
* disability in the exams.
Minimum Eligible Age

40 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Rio de Janeiro State University

OTHER

Sponsor Role lead

Responsible Party

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Karla Dames

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Pedro L de Melo, DSc.

Role: STUDY_DIRECTOR

State University of Rio de Janeiro

Locations

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Laboratório de Instrumentação Biomédica

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status RECRUITING

Countries

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Brazil

Facility Contacts

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Karla Dames, Principal Investigator

Role: primary

References

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Silva KK, Faria AC, Lopes AJ, Melo PL. Within-breath respiratory impedance and airway obstruction in patients with chronic obstructive pulmonary disease. Clinics (Sao Paulo). 2015 Jul;70(7):461-9. doi: 10.6061/clinics/2015(07)01. Epub 2015 Jul 1.

Reference Type DERIVED
PMID: 26222814 (View on PubMed)

Other Identifiers

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UERJ-DPOC-01

Identifier Type: -

Identifier Source: org_study_id