Activity of Inspiratory Muscles With the Use of Positive Pressure in Patients With Chronic Obstructive Pulmonary Disease

NCT ID: NCT01111487

Last Updated: 2011-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-09-30

Brief Summary

The objective is to evaluate whether the use of expiratory positive airway pressure (EPAP) reduces the electrical activity of the sternocleidomastoid muscle and enhances the action of the muscle in the patient parasternal ported from Chronic Obstructive Pulmonary Disease. Noting also, if the set pressure level (10 or 15 cmH2O) affects this relationship.

Detailed Description

The chronic obstructive pulmonary disease (COPD) is characterized by chronic obstruction to airflow, which leads to respiratory muscle overload and greater activation of accessory muscles of respiration, especially those active in the inspiratory phase. It is believed that the positive expiratory pressure (EPAP) reduces respiratory work, producing less activation of these muscles. Thus, we evaluate the behavior of the electrical activity of inspiratory muscles of COPD patients in response to application of expiratory positive airway pressure (EPAP), and to observe the influence of pressure level in inspiratory muscle recruitment. This will be implemented for a clinical single blinded trial (blinded to gauge the outcome) developed in the Department of Pneumology, Hospital de Clinicas de Porto Alegre (HCPA). Will be evaluated in COPD patients with a clinical diagnosis of pathology, and of both genders and should be aged between 40 and 70 years. In a first day will be collected anthropometric data, performed the lung function test for the staging of pathology and muscle strength testing. These same individuals will return to evaluate the electromyographic activity of sternocleidomastoid (SCM), and parasternal, both from the right hemisphere. This evaluation will consist in the measurement during breathing at rest (control), with the implementation of EPAP mask 10 or 15 cmH2O (state intervention) and 10 minutes after its removal. To test the lung function will be assessed using a spirometer and the lung capacity compared to the predicted in literature. As the electrical activity of muscle, will be observed the percentage of activation obtained for the highest activity (% RMS). Thus, it is expected that the implementation of EPAP promotes reduction of the electrical activity of muscle ECM and leverage the action of the parasternal muscle, affected by dynamic hyperinflation. It is also hoped that the use of blood pressure level of 15 cmH2O, compared to 10 cmH2O, the leverage effect of EPAP on the muscles of interest. The surface electromyographic evaluation is a method of relatively inexpensive and noninvasive, and is effective in evaluating the electrical potential that lies on the muscle membrane. So, will describe the effect of EPAP on the inspiratory muscles, which will be important to guide treatment of COPD patients using positive airway pressure therapy.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group I

This group will use a pressure level of 10 cmH2O.

Group Type: ACTIVE_COMPARATOR

Expiratory positive airway pressure (EPAP) by face mask.

Intervention Type: DEVICE

Implementation of the EPAP as group pressure, 10 or 15 cmH2O, for 20 minutes then evaluated the electromyographic activity of muscles and sternocleidomastoid parasternal the tenth and twentieth minutes of your application.

Group II

This group will use a pressure level of 15 cmH2O.

Group Type: ACTIVE_COMPARATOR

Expiratory positive airway pressure (EPAP) by face mask.

Intervention Type: DEVICE

Implementation of the EPAP as group pressure, 10 or 15 cmH2O, for 20 minutes then evaluated the electromyographic activity of muscles and sternocleidomastoid parasternal the tenth and twentieth minutes of your application.

Interventions

Expiratory positive airway pressure (EPAP) by face mask.

Implementation of the EPAP as group pressure, 10 or 15 cmH2O, for 20 minutes then evaluated the electromyographic activity of muscles and sternocleidomastoid parasternal the tenth and twentieth minutes of your application.

Intervention Type: DEVICE

Other Intervention Names

PEP-mask

Eligibility Criteria

Inclusion Criteria

• Diagnosis of COPD in stage II or III according to classification of the Global Initiative for Chronic Obstructive Lung Disease (GOLD);
• Signing the consent form;
• Stability of clinical pathology, with no signs of exacerbation in the 30 (thirty) days prior to the inclusion in the study.

Exclusion Criteria

• Individuals would use artificial airway;
• Hemodynamic instability;
• Body mass index (BMI) above the values considered as obese (> 30Kg/m2).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role: lead

Responsible Party

Dannuey Machado Cardoso

Post graduation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sérgio S Menna Barreto, Dr

Role: PRINCIPAL_INVESTIGATOR

Hospital of Clinicas of Porto Alegre

Locations

HCPA - Hospital of Clinicas of Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

University of Santa Cruz do Sul

Santa Cruz do Sul, Rio Grande do Sul, Brazil

Countries

Brazil

References

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Reference Type: RESULT

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Other Identifiers

09-500

Identifier Type: -

Identifier Source: org_study_id