Набор скоро начнётся NCT07125989

Effect of Exercise Ventilatory Support Pressure on Endurance in Patients With Severe Chronic Obstructive Pulmonary Disease - AVE-BPCO

Без фазы С лечением Chronic Obstructive Pulmonary Disease (COPD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: non-invasive ventilation.
Кому может быть актуально: Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Обзор

Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by progressive obstruction of the airways. In advanced stages, it can progress to chronic respiratory failure with major respiratory repercussions. Biologically, hyperinflation manifests as alveolar hypoventilation, which causes hypercapnia. Mechanically, it is responsible for an increase in ventilatory work associated with diaphragmatic muscle dysfunction and fatigue, leading to exercise incapacity. Physical inactivity is a major predictor of mortality in patients with COPD. The recommendations of the European Respiratory Society (ERS) and the American Thoracic Society (ATS) emphasize the importance of exercise in the treatment and management of COPD. Respiratory rehabilitation has been shown to have an indisputable effect on dyspnea and the quality of life of COPD patients. Current guidelines for respiratory rehabilitation recommend interventions at a frequency of at least 2 to 3 supervised high-intensity training sessions per week. A minimum of 4 weeks of physical training is necessary to achieve a significant improvement in quality of life, dyspnea, and endurance. A reduction in the duration and intensity of sessions is often necessary, thus limiting the desired benefits of respiratory rehabilitation. Non-invasive ventilation (NIV) provides mechanical respiratory assistance by helping inspiration and optimizing expiration through a non-invasive interface such as a mask. Its use during exercise in severe COPD is to try to correct hypercapnia, reduce dynamic hyperinflation by helping the respiratory muscles to improve their work, and reduce dyspnea and the feeling of muscle weakness. However, the modalities in terms of ventilation mode and inspiratory support pressures are not clearly established.

Подробное описание

The objective of this study is therefore to compare different levels of ventilatory assistance during exercise to determine whether the level of inspiratory assistance during exercise significantly improves endurance in these patients and, in particular, whether high-intensity ventilatory assistance (inspiratory assistance 21 +/- 3 cmH20) provides a greater benefit in terms of endurance time compared to moderate intensity (inspiratory assistance 13 +/- 3 cmH20) or low intensity (inspiratory assistance \< 6 cmH20).

Вмешательства

Устройство non-invasive ventilation
During the patient's first three respiratory rehabilitation sessions, each test on the cycle ergometer will be performed at 70% of maximum power (defined during the initial oxygen consumption (VO2) test) with ventilatory assistance at a different intensity (Low, moderate or high intensity).

Первичные конечные точки

Pedaling time limit (in seconds) [Срок оценки: Day 1, Day 3, Day 5]

Вторичные конечные точки (4)

Partial pressure of oxygen (PaO2) in mmHg [Срок оценки: Day 1, Day 3, Day 5]
Partial pressure of carbon dioxide (PaCO2) in mmHg [Срок оценки: Day 1, Day 3, Day 5]
Lactate in mmol/l [Срок оценки: Day 1, Day 3, Day 5]
Peripheral muscle oxygenation (% SmO2) [Срок оценки: Day 1, Day 3, Day 5]

Критерии участия

Критерии включения

-COPD stage GOLD III or IV
Baseline hypercapnia PaCO2 > 45 mmHg OR Alveolar hypoventilation during exercise (increase in PaCO2 > 5 mmHg),
Exhaustion of more than 80% of ventilatory reserve OR max power < 50 Watts
Affiliation or entitlement to social security coverage
Signature of informed consent