- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02012101
Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD
23. juni 2014 oppdatert av: Yonger Ou, Guangzhou Institute of Respiratory Disease
The Efficacy of Non-invasive Mechanical Ventilation as a Rescue Therapy for Relieving Dyspnea in Patients With Stable Severe COPD
The purpose of this study is to determine whether non-invasive mechanical ventilation(NIV), playing the role as a rescue therapy , are effective in relieving exertional dyspnea in stable severe COPD patients.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Chronic obstructive pulmonary disease(COPD) is a preventable and treatable illness, which is clinically characterized by persistent airflow limitation that is usually progressive.
It's well known that airflow limitation lead to air trapping particularly during exercise, resulting in increased dyspnea and limitation of exercise capacity.
Thus, COPD patients often unconsciously adopt a sedentary lifestyle, probably due to distressing exertional dyspnea.
The sedentarism results in physical deconditioning and alterations of the peripheral muscles, and the latter one causes more exertional dyspnea and fatigue, which in turn leads to much more sedentarism, forming the vicious cycle of sedentarism, dyspnea/fatigue and more sedentarism.
Thereby, measures should be taken to interrupt this vicious cycle.
Some previous studies suggested that niv acting as an add-on therapy could help unloading the inspiratory muscle, reducing the dynamic compression of the airway, diminishing the dynamic hyperinflation,to some extent, relieved dyspnea during exercise in COPD patients.
However,those measures were taken during exercise, acting as an add-on therapy.
Whether NIV can play a role as a rescue therapy to relieve exertional dyspnea while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication is still not quite clear.
Therefore, we hypothesize that niv as a rescue-therapy has the same effect on relieving dyspnea in stable severe COPD patients just like the add-on therapy.
Studietype
Intervensjonell
Registrering (Faktiske)
18
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Guangdong
-
Guangzhou, Guangdong, Kina, 510120
- State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
-
-
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
30 år til 80 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- severe COPD (post bronchodilator FEV1/FVC < 70% and FEV1 < 50% predicted)
- stable clinical condition(no exacerbation in the 4 weeks prior to study participation with no change in medications)
- dyspnea as a main symptom that limited daily activities
Exclusion Criteria:
- obvious pulmonary bullae demonstrated by chest CT scan or X-ray examination
- facial trauma/malformation; recent facial, upper airway or upper gastrointestinal tract surgery
- oxygen saturation(SpO2) < 88% at rest with a fraction of inspired oxygen(FiO2) ≥ 0.5
- systolic blood pressure > 160mmHg or diastolic blood pressure > 100mmHg at rest
- unstable angina or a myocardial infarct in the previous four weeks
- resting sinus tachycardia ( > 120 beats/min)
- patients with musculoskeletal or neurological disorders
- patients who are unable to give informed consent
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: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: niv plus oxygen therapy
oxygen therapy is given during the whole experimental process, niv is given at peak exercise until the borg scale reaches it's baseline point
|
NIV given on Philips Respironics BiPAP Vision apparatus.
Andre navn:
|
|
Aktiv komparator: oxygen therapy
oxygen therapy is given during the whole experimental process
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Borg scale
Tidsramme: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Inspiratory capacity(IC)
Tidsramme: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
|
|
|
surface electromyography(sEMG)
Tidsramme: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
|
|
|
respiratory parameters
Tidsramme: baseline,repeated measurement for about ten minutes after intervention
|
minute ventilation(VE); tidal volume(Vt); respiratory rate(RR); inspiratory time(Ti); total duty cycle(Ttot)
|
baseline,repeated measurement for about ten minutes after intervention
|
|
oxygen saturation(SpO2)
Tidsramme: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
|
|
|
Heart Rate(HR)
Tidsramme: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
|
|
|
the total recovery time
Tidsramme: repeated measurement for about ten minutes after intervention
|
repeated measurement for about ten minutes after intervention
|
|
|
mouth pressure(Pmo)
Tidsramme: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Rongchang Chen, M.D., Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
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. mars 2013
Primær fullføring (Faktiske)
1. april 2014
Studiet fullført (Faktiske)
1. april 2014
Datoer for studieregistrering
Først innsendt
8. desember 2013
Først innsendt som oppfylte QC-kriteriene
13. desember 2013
Først lagt ut (Anslag)
16. desember 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
24. juni 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
23. juni 2014
Sist bekreftet
1. juni 2014
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2009CB522111
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. .