NCT01111487

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2009

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 27, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

1.7 years

First QC Date

April 26, 2010

Last Update Submit

September 25, 2011

Conditions

Keywords

COPDElectromyographyInspiratory muscles

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Group I

ACTIVE COMPARATOR

This group will use a pressure level of 10 cmH2O.

Device: Expiratory positive airway pressure (EPAP) by face mask.

Group II

ACTIVE COMPARATOR

This group will use a pressure level of 15 cmH2O.

Device: Expiratory positive airway pressure (EPAP) by face mask.

Interventions

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.

Also known as: PEP-mask
Group IGroup II

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

HCPA - Hospital of Clinicas of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90040-060, Brazil

Location

University of Santa Cruz do Sul

Santa Cruz do Sul, Rio Grande do Sul, 96815-900, Brazil

Location

Related Publications (8)

  • 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.

    PMID: 19608926BACKGROUND
  • 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.

    PMID: 12871677BACKGROUND
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Sérgio S Menna Barreto, Dr

    Hospital of Clinicas of Porto Alegre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post graduation

Study Record Dates

First Submitted

April 26, 2010

First Posted

April 27, 2010

Study Start

November 1, 2009

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09

Locations