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

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Expiratory positive airway pressure (EPAP) by face mask.
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring COPD, Electromyography, Inspiratory muscles

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • HCPA - Hospital of Clinicas of Porto Alegre
  • Federal University of Rio Grande do Sul
  • University of Santa Cruz do Sul

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group I

Group II

Arm Description

This group will use a pressure level of 10 cmH2O.

This group will use a pressure level of 15 cmH2O.

Outcomes

Primary Outcome Measures

Electromyographic activity of muscles and sternocleidomastoid parasternal
An average baseline, before the use of expiratory positive airway pressure (EPAP) to be compared with two-mediated during the 20 minutes of application of EPAP and 10 minutes after its removal.

Secondary Outcome Measures

Full Information

First Posted
April 26, 2010
Last Updated
September 25, 2011
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01111487
Brief Title
Activity of Inspiratory Muscles With the Use of Positive Pressure in Patients With Chronic Obstructive Pulmonary Disease
Official Title
Inspiratory Muscle Recruitment in COPD Patients With the Use of Expiratory Positive Airways Pressure
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, Electromyography, Inspiratory muscles

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Active Comparator
Arm Description
This group will use a pressure level of 10 cmH2O.
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
This group will use a pressure level of 15 cmH2O.
Intervention Type
Device
Intervention Name(s)
Expiratory positive airway pressure (EPAP) by face mask.
Other Intervention Name(s)
PEP-mask
Intervention Description
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.
Primary Outcome Measure Information:
Title
Electromyographic activity of muscles and sternocleidomastoid parasternal
Description
An average baseline, before the use of expiratory positive airway pressure (EPAP) to be compared with two-mediated during the 20 minutes of application of EPAP and 10 minutes after its removal.
Time Frame
20 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sérgio S Menna Barreto, Dr
Organizational Affiliation
Hospital of Clinicas of Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
HCPA - Hospital of Clinicas of Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Federal University of Rio Grande do Sul
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90040-060
Country
Brazil
Facility Name
University of Santa Cruz do Sul
City
Santa Cruz do Sul
State/Province
Rio Grande do Sul
ZIP/Postal Code
96815-900
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
19608926
Citation
Legrand A, Majcher M, Joly E, Bonaert A, Gevenois PA. Neuromechanical matching of drive in the scalene muscle of the anesthetized rabbit. J Appl Physiol (1985). 2009 Sep;107(3):741-8. doi: 10.1152/japplphysiol.91320.2008. Epub 2009 Jul 16.
Results Reference
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PubMed Identifier
12871677
Citation
Yokoba M, Abe T, Katagiri M, Tomita T, Easton PA. Respiratory muscle electromyogram and mouth pressure during isometric contraction. Respir Physiol Neurobiol. 2003 Aug 14;137(1):51-60. doi: 10.1016/s1569-9048(03)00092-2.
Results Reference
background
PubMed Identifier
9309997
Citation
Yan S, Kaminski D, Sliwinski P. Inspiratory muscle mechanics of patients with chronic obstructive pulmonary disease during incremental exercise. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):807-13. doi: 10.1164/ajrccm.156.3.9702104.
Results Reference
result
PubMed Identifier
17690147
Citation
Hudson AL, Gandevia SC, Butler JE. The effect of lung volume on the co-ordinated recruitment of scalene and sternomastoid muscles in humans. J Physiol. 2007 Oct 1;584(Pt 1):261-70. doi: 10.1113/jphysiol.2007.137240. Epub 2007 Aug 9.
Results Reference
result
PubMed Identifier
13251968
Citation
CAMPBELL EJ. The role of the scalene and sternomastoid muscles in breathing in normal subjects; an electromyographic study. J Anat. 1955 Jul;89(3):378-86. No abstract available.
Results Reference
result
PubMed Identifier
16777998
Citation
Levine S, Nguyen T, Friscia M, Zhu J, Szeto W, Kucharczuk JC, Tikunov BA, Rubinstein NA, Kaiser LR, Shrager JB. Parasternal intercostal muscle remodeling in severe chronic obstructive pulmonary disease. J Appl Physiol (1985). 2006 Nov;101(5):1297-302. doi: 10.1152/japplphysiol.01607.2005. Epub 2006 Jun 15.
Results Reference
result
PubMed Identifier
8339634
Citation
Lien TC, Wang JH, Chang MT, Kuo CD. Comparison of BiPAP nasal ventilation and ventilation via iron lung in severe stable COPD. Chest. 1993 Aug;104(2):460-6. doi: 10.1378/chest.104.2.460.
Results Reference
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PubMed Identifier
8131541
Citation
van der Schans CP, de Jong W, de Vries G, Kaan WA, Postma DS, Koeter GH, van der Mark TW. Effects of positive expiratory pressure breathing during exercise in patients with COPD. Chest. 1994 Mar;105(3):782-9. doi: 10.1378/chest.105.3.782.
Results Reference
result

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

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