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

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Device: niv plus oxygen therapy; Device: oxygen therapy

• Registration Number: NCT02012101
• Lead Sponsor: Guangzhou Institute of Respiratory Disease

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.

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-12-08
• Study First Submitted QC: 2013-12-13
• Study First Posted: 2013-12-16
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
niv plus oxygen therapy	niv plus oxygen therapy	oxygen therapy is given during the whole experimental process, niv is given at peak exercise until the borg scale reaches it's baseline point
oxygen therapy	oxygen therapy	oxygen therapy is given during the whole experimental process

Primary Outcome Measures

Name	Time	Method
Borg scale	baseline,repeated measurement for about ten minutes after intervention

Secondary Outcome Measures

Name	Time	Method
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	minute 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
Heart Rate(HR)	baseline,repeated measurement for about ten minutes after intervention
the total recovery time	repeated measurement for about ten minutes after intervention

Trial Locations

Locations (1)

State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College; 🇨🇳 Guangzhou, Guangdong, China