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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Device: niv plus oxygen therapy; Device: oxygen therapy

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 Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: niv plus oxygen therapy; NIV given on Philips Respironics BiPAP Vision apparatus.; Other Names: Philips Respironics BiPAP Vision
Active Comparator: oxygen therapy; oxygen therapy is given during the whole experimental process	Device: oxygen therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Borg scale	baseline,repeated measurement for about ten minutes after intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inspiratory capacity(IC)		baseline,repeated measurement for about ten minutes after intervention
surface electromyography(sEMG)		baseline,repeated measurement for about ten minutes after intervention
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
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
mouth pressure(Pmo)		baseline,repeated measurement for about ten minutes after intervention

Collaborators and Investigators

• Sponsor: Guangzhou Institute of Respiratory Disease
• Investigators: Principal Investigator: Rongchang Chen, M.D., Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 8, 2013
• First Submitted That Met QC Criteria: December 13, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): June 24, 2014
• Last Update Submitted That Met QC Criteria: June 23, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: exercise; COPD; Noninvasive Ventilation; dyspnea
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Signs and Symptoms, Respiratory; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
• Other Study ID Numbers: 2009CB522111