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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03568747
Efficacy and Mechanism of NIV in Relieving Dyspnea After Exercise in Patients With Stable Severe COPD
29 de julio de 2019 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
12
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Guangdong
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Guangzhou, Guangdong, Porcelana, 510000
- The First Affiliated Hospital of Guangzhou Medical University
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: NIV plus oxygen therapy
noninvasive ventilation (dual-limb NIV) is given at peak exercise until the borg scale reaches it's baseline point
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dual-limb circuit NIV were given on maquet servo i apparatus
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Experimental: oxygen therapy
oxygen therapy is given at peak exercise until the borg scale reaches it's baseline point
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oxygen therapy were introduced to the side port of the facemask
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change from baseline Borg scale to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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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.
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baseline, at peak exercise and at every 30s interval until complete recovery
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change from baseline diaphragm electromyogram to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
|
EMGdi
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline index of neuromechanical dissociation of the respiratory system to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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EMGdi%max:Vt%VCpred
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baseline, at peak exercise and at every 30s interval until complete recovery
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
change from baseline transdiaphragmatic pressure to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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Pdi
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline esophageal pressure to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
|
Pes
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline mouth pressure to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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Pm
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline inspiratory capacity to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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IC
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline minute ventilation to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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VE
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline oxygen saturation to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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SpO2
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline heart rate to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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HR
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline total recovery time to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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total recovery time
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline tidal volume to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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Vt
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baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline respiratory rate to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
|
RR
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baseline, at peak exercise and at every 30s interval until complete recovery
|
change from baseline inspiratory time to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
|
Ti
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline total duty cycle to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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Ttot
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline expiratory time to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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Te
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baseline, at peak exercise and at every 30s interval until complete recovery
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change from baseline pressure time product to complete recovery after exercise
Periodo de tiempo: baseline, at peak exercise and at every 30s interval until complete recovery
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PTP
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baseline, at peak exercise and at every 30s interval until complete recovery
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Rongchang Chen, The First Affiliated Hospital of Guangzhou Medical University
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
23 de junio de 2018
Finalización primaria (Actual)
3 de febrero de 2019
Finalización del estudio (Actual)
30 de abril de 2019
Fechas de registro del estudio
Enviado por primera vez
30 de mayo de 2018
Primero enviado que cumplió con los criterios de control de calidad
14 de junio de 2018
Publicado por primera vez (Actual)
26 de junio de 2018
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de julio de 2019
Última actualización enviada que cumplió con los criterios de control de calidad
29 de julio de 2019
Última verificación
1 de junio de 2018
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GIRD201801
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre noninvasive ventilation
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