- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01111487
Activity of Inspiratory Muscles With the Use of Positive Pressure in Patients With Chronic Obstructive Pulmonary Disease
25. september 2011 oppdatert av: Dannuey Machado Cardoso, Hospital de Clinicas de Porto Alegre
Inspiratory Muscle Recruitment in COPD Patients With the Use of Expiratory Positive Airways Pressure
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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Registrering (Forventet)
40
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 90040-060
- Federal University of Rio Grande do Sul
-
Porto Alegre, Rio Grande do Sul, Brasil, 90035-903
- HCPA - Hospital of Clinicas of Porto Alegre
-
Santa Cruz do Sul, Rio Grande do Sul, Brasil, 96815-900
- University of Santa Cruz do Sul
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
40 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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).
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: Group I
This group will use a pressure level of 10 cmH2O.
|
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.
Andre navn:
|
Aktiv komparator: Group II
This group will use a pressure level of 15 cmH2O.
|
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.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Electromyographic activity of muscles and sternocleidomastoid parasternal
Tidsramme: 20 minutes
|
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Sérgio S Menna Barreto, Dr, Hospital of Clinicas of Porto Alegre
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2009
Primær fullføring (Faktiske)
1. august 2011
Studiet fullført (Faktiske)
1. september 2011
Datoer for studieregistrering
Først innsendt
26. april 2010
Først innsendt som oppfylte QC-kriteriene
26. april 2010
Først lagt ut (Anslag)
27. april 2010
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
27. september 2011
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. september 2011
Sist bekreftet
1. september 2011
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 09-500
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .