- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02012101
Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD
23 juni 2014 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
18
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Guangdong
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Guangzhou, Guangdong, Kina, 510120
- State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
30 år till 80 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Crossover tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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
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NIV given on Philips Respironics BiPAP Vision apparatus.
Andra namn:
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Aktiv komparator: oxygen therapy
oxygen therapy is given during the whole experimental process
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Borg scale
Tidsram: baseline,repeated measurement for about ten minutes after intervention
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baseline,repeated measurement for about ten minutes after intervention
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Inspiratory capacity(IC)
Tidsram: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
|
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surface electromyography(sEMG)
Tidsram: baseline,repeated measurement for about ten minutes after intervention
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baseline,repeated measurement for about ten minutes after intervention
|
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respiratory parameters
Tidsram: baseline,repeated measurement for about ten minutes after intervention
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minute ventilation(VE); tidal volume(Vt); respiratory rate(RR); inspiratory time(Ti); total duty cycle(Ttot)
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baseline,repeated measurement for about ten minutes after intervention
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oxygen saturation(SpO2)
Tidsram: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
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Heart Rate(HR)
Tidsram: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
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the total recovery time
Tidsram: repeated measurement for about ten minutes after intervention
|
repeated measurement for about ten minutes after intervention
|
|
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mouth pressure(Pmo)
Tidsram: baseline,repeated measurement for about ten minutes after intervention
|
baseline,repeated measurement for about ten minutes after intervention
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Rongchang Chen, M.D., Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2013
Primärt slutförande (Faktisk)
1 april 2014
Avslutad studie (Faktisk)
1 april 2014
Studieregistreringsdatum
Först inskickad
8 december 2013
Först inskickad som uppfyllde QC-kriterierna
13 december 2013
Första postat (Uppskatta)
16 december 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
24 juni 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
23 juni 2014
Senast verifierad
1 juni 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2009CB522111
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