Clinical trial NCT02012101: Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD
Official title: The Efficacy of Non-invasive Mechanical Ventilation as a Rescue Therapy for Relieving Dyspnea in Patients With Stable Severe COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
dyspnea
exercise
Noninvasive Ventilation
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2013-12-16
Enrollment: 18
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Borg scale
timeFrame: baseline,repeated measurement for about ten minutes after intervention
Secondary outcomes:
measure: Inspiratory capacity(IC)
timeFrame: baseline,repeated measurement for about ten minutes after intervention
measure: surface electromyography(sEMG)
timeFrame: baseline,repeated measurement for about ten minutes after intervention
measure: respiratory parameters
timeFrame: baseline,repeated measurement for about ten minutes after intervention
measure: oxygen saturation(SpO2)
timeFrame: baseline,repeated measurement for about ten minutes after intervention
measure: Heart Rate(HR)
timeFrame: baseline,repeated measurement for about ten minutes after intervention
measure: the total recovery time
timeFrame: repeated measurement for about ten minutes after intervention
measure: mouth pressure(Pmo)
timeFrame: baseline,repeated measurement for about ten minutes after intervention
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
state: Guangdong
Study officials:
affiliation: Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
name: Rongchang Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: