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Clinical Trials/NCT02012101
NCT02012101
Completed
N/A

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

Guangzhou Institute of Respiratory Disease1 site in 1 country18 target enrollmentMarch 2013

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
Guangzhou Institute of Respiratory Disease
Enrollment
18
Locations
1
Primary Endpoint
Borg scale
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2013
End Date
April 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Guangzhou Institute of Respiratory Disease
Responsible Party
Principal Investigator
Principal Investigator

Yonger Ou

MMSc

Guangzhou Institute of Respiratory Disease

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

Outcomes

Primary Outcomes

Borg scale

Time Frame: baseline,repeated measurement for about ten minutes after intervention

Secondary Outcomes

  • Inspiratory capacity(IC)(baseline,repeated measurement for about ten minutes after intervention)
  • surface electromyography(sEMG)(baseline,repeated measurement for about ten minutes after intervention)
  • mouth pressure(Pmo)(baseline,repeated measurement for about ten minutes after intervention)
  • respiratory parameters(baseline,repeated measurement for about ten minutes after intervention)
  • oxygen saturation(SpO2)(baseline,repeated measurement for about ten minutes after intervention)
  • Heart Rate(HR)(baseline,repeated measurement for about ten minutes after intervention)
  • the total recovery time(repeated measurement for about ten minutes after intervention)

Study Sites (1)

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