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Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD

The Efficacy of Non-invasive Mechanical Ventilation as a Rescue Therapy for Relieving Dyspnea in Patients With Stable Severe COPD

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02012101
Enrollment
18
Registered
2013-12-16
Start date
2013-03-31
Completion date
2014-04-30
Last updated
2014-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, dyspnea, exercise, Noninvasive Ventilation

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.

Interventions

DEVICEniv plus oxygen therapy

NIV given on Philips Respironics BiPAP Vision apparatus.

DEVICEoxygen therapy

Sponsors

Guangzhou Institute of Respiratory Disease
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Borg scalebaseline,repeated measurement for about ten minutes after intervention

Secondary

MeasureTime frameDescription
surface electromyography(sEMG)baseline,repeated measurement for about ten minutes after intervention
respiratory parametersbaseline,repeated measurement for about ten minutes after interventionminute ventilation(VE); tidal volume(Vt); respiratory rate(RR); inspiratory time(Ti); total duty cycle(Ttot)
oxygen saturation(SpO2)baseline,repeated measurement for about ten minutes after intervention
Inspiratory capacity(IC)baseline,repeated measurement for about ten minutes after intervention
the total recovery timerepeated measurement for about ten minutes after intervention
mouth pressure(Pmo)baseline,repeated measurement for about ten minutes after intervention
Heart Rate(HR)baseline,repeated measurement for about ten minutes after intervention

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026