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

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

Official title:

Inspiratory Muscle Recruitment in COPD Patients With the Use of Expiratory Positive Airways Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111487
• Other study ID #: 09-500
• Status: Completed
• Phase: N/A
• First received: April 26, 2010
• Last updated: September 25, 2011
• Start date: November 2009
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Rio Grande do Sul	Porto Alegre	Rio Grande do Sul
Brazil	HCPA - Hospital of Clinicas of Porto Alegre	Porto Alegre	Rio Grande do Sul
Brazil	University of Santa Cruz do Sul	Santa Cruz do Sul	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View 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. Epub 2007 Aug 9. — View 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. — View 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. Epu — View 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. — View Citation

van der Schans CP, de Jong W, de Vries G, Kaan WA, Postma DS, Koëter GH, van der Mark TW. Effects of positive expiratory pressure breathing during exercise in patients with COPD. Chest. 1994 Mar;105(3):782-9. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	20 minutes	No