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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02012101
• Other study ID #: 2009CB522111
• Status: Completed
• Phase: N/A
• First received: December 8, 2013
• Last updated: June 23, 2014
• Start date: March 2013
• Est. completion date: April 2014

Study information

• Verified date: June 2014
• Source: Guangzhou Institute of Respiratory Disease
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• niv plus oxygen therapy
NIV given on Philips Respironics BiPAP Vision apparatus.
• oxygen therapy

Locations

Country	Name	City	State
China	State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Institute of Respiratory Disease

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Borg scale		baseline,repeated measurement for about ten minutes after intervention	No
Secondary	Inspiratory capacity(IC)		baseline,repeated measurement for about ten minutes after intervention	No
Secondary	surface electromyography(sEMG)		baseline,repeated measurement for about ten minutes after intervention	No
Secondary	respiratory parameters	minute ventilation(VE); tidal volume(Vt); respiratory rate(RR); inspiratory time(Ti); total duty cycle(Ttot)	baseline,repeated measurement for about ten minutes after intervention	No
Secondary	oxygen saturation(SpO2)		baseline,repeated measurement for about ten minutes after intervention	No
Secondary	Heart Rate(HR)		baseline,repeated measurement for about ten minutes after intervention	No
Secondary	the total recovery time		repeated measurement for about ten minutes after intervention	No
Secondary	mouth pressure(Pmo)		baseline,repeated measurement for about ten minutes after intervention	No