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

29 июля 2019 г. обновлено: 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.

Обзор исследования

Подробное описание

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.

Тип исследования

Интервенционный

Регистрация (Действительный)

12

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 40 лет до 80 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Описание

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

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Назначение кроссовера
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: 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
Экспериментальный: 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

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
change from baseline Borg scale to complete recovery after exercise
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
change from baseline diaphragm electromyogram to complete recovery after exercise
Временное ограничение: 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
Временное ограничение: 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

Другие показатели результатов

Мера результата
Мера Описание
Временное ограничение
change from baseline transdiaphragmatic pressure to complete recovery after exercise
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Следователи

  • Директор по исследованиям: Rongchang Chen, The First Affiliated Hospital of Guangzhou Medical University

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

23 июня 2018 г.

Первичное завершение (Действительный)

3 февраля 2019 г.

Завершение исследования (Действительный)

30 апреля 2019 г.

Даты регистрации исследования

Первый отправленный

30 мая 2018 г.

Впервые представлено, что соответствует критериям контроля качества

14 июня 2018 г.

Первый опубликованный (Действительный)

26 июня 2018 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

30 июля 2019 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

29 июля 2019 г.

Последняя проверка

1 июня 2018 г.

Дополнительная информация

Термины, связанные с этим исследованием

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Клинические исследования noninvasive ventilation

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