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Efficacy and Mechanism of NIV in Relieving Dyspnea After Exercise in Patients With Stable Severe COPD

29 lipca 2019 zaktualizowane przez: Yonger Ou, Guangzhou Institute of Respiratory Disease

Efficacy and Mechanism of Non-invasive Ventilation in Relieving Dyspnea After Exercise in Patients With Stable Severe Chronic Obstructive Pulmonary Disease

Exertional dyspnea is a major cause of exercise limitation and anxiety, and contributes importantly to reduced quality of life for patients with COPD. The aim of this study is to determine the efficacy and mechanism of NIV with a dual-limb circuit plus oxygen therapy in relieving exertional dyspnea in patients with severe COPD, so as to provide a guidance for clinical use for NIV.

Przegląd badań

Szczegółowy opis

Exertional dyspnea was the most characteristic respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD), it is a major cause of exercise limitation and anxiety, and contributes importantly to reduced quality of life for patients with COPD. 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, which leads to a vicious circle and contribute to the debilitation of the patients. Thereby, intervention should be taken to intervene this vicious cycle. It has been reported that noninvasive ventilation (NIV) could help unload the inspiratory muscle, improve dynamic pulmonary hyperinflation, improve neuro-mechanical coupling, oxygenation, and thus relieved dyspnea during exercise in COPD patients. However, in these reports, NIV was used as add-on therapy during exercise or at resting condition before exertional dyspnea occurred. So far, there's few studies on the efficacy of NIV used at the time of exertional dyspnea occurred as the rescue therapy to relieve dyspnea after exercise in patients with stable severe COPD while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication, which might relieve their physiological and perceptional burden to limit their activities. The result of the investigators previous study has suggested that compared with oxygen therapy, NIV plus oxygen therapy resulted in decrease in dyspnea intensity at isotime, however, there's no statistically significant shortening in total dyspnea recovery time and NIV was not helpful in all the COPD patients. In another study, it was indicated that ventilated by a single-limb tubing with a plateau exhalation valve (PEV) caused CO2 rebreathing to COPD patients during exercise. CO2 rebreathing may have a negative impact on efficacy. Previous studies have proved that exercise tolerance was improved ventilated by noninvasive ventilation with a dual-limb circuit. In theory, NIV with a dual-limb circuit consists of one inhalation limb that introduces air into the patient's airways and one exhalation limb that leads exhaled gas outside of the airways, there is no risk of rebreathing. However, it is unclear whether NIV with a dual-limb circuit could be used at the time of exertional dyspnea occurred as rescue therapy to relieve dyspnea after exercise in patients with stable severe COPD and what are the mechanisms. The purpose of this study was therefore to determine whether assisted with NIV with dual-limb circuit in patients with stable severe COPD after exercise with exertional dyspnea (1)dyspnea was relieved after exercise in patients with stable severe COPD; (2)the repiratory mechanism.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

12

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

    • Guangdong
      • Guangzhou, Guangdong, Chiny, 510000
        • The First Affiliated Hospital of Guangzhou Medical University

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

40 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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
  • 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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: NIV plus oxygen therapy
noninvasive ventilation (dual-limb NIV) is given at peak exercise until the borg scale reaches it's baseline point
dual-limb circuit NIV were given on maquet servo i apparatus
Eksperymentalny: oxygen therapy
oxygen therapy is given at peak exercise until the borg scale reaches it's baseline point
oxygen therapy were introduced to the side port of the facemask

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
change from baseline Borg scale to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
this is a scale that asks the participants to rate the difficulty of breathing. It starts at number 0 where one's breathing is causing no difficulty at all and progresses through to number 10 where one's breathing difficulty is maximal.
baseline, at peak exercise and at every 30s interval until complete recovery

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
change from baseline diaphragm electromyogram to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
EMGdi
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline index of neuromechanical dissociation of the respiratory system to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
EMGdi%max:Vt%VCpred
baseline, at peak exercise and at every 30s interval until complete recovery

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
change from baseline transdiaphragmatic pressure to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
Pdi
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline esophageal pressure to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
Pes
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline mouth pressure to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
Pm
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline inspiratory capacity to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
IC
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline minute ventilation to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
VE
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline oxygen saturation to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
SpO2
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline heart rate to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
HR
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline total recovery time to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
total recovery time
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline tidal volume to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
Vt
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline respiratory rate to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
RR
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline inspiratory time to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
Ti
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline total duty cycle to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
Ttot
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline expiratory time to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
Te
baseline, at peak exercise and at every 30s interval until complete recovery
change from baseline pressure time product to complete recovery after exercise
Ramy czasowe: baseline, at peak exercise and at every 30s interval until complete recovery
PTP
baseline, at peak exercise and at every 30s interval until complete recovery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

  • Dyrektor Studium: Rongchang Chen, The First Affiliated Hospital of Guangzhou Medical University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

23 czerwca 2018

Zakończenie podstawowe (Rzeczywisty)

3 lutego 2019

Ukończenie studiów (Rzeczywisty)

30 kwietnia 2019

Daty rejestracji na studia

Pierwszy przesłany

30 maja 2018

Pierwszy przesłany, który spełnia kryteria kontroli jakości

14 czerwca 2018

Pierwszy wysłany (Rzeczywisty)

26 czerwca 2018

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

30 lipca 2019

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

29 lipca 2019

Ostatnia weryfikacja

1 czerwca 2018

Więcej informacji

Terminy związane z tym badaniem

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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