Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
niv plus oxygen therapy
oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, dyspnea, exercise, Noninvasive Ventilation
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
Sites / Locations
- State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
niv plus oxygen therapy
oxygen therapy
Arm Description
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 is given during the whole experimental process
Outcomes
Primary Outcome Measures
Borg scale
Secondary Outcome Measures
Inspiratory capacity(IC)
surface electromyography(sEMG)
respiratory parameters
minute ventilation(VE); tidal volume(Vt); respiratory rate(RR); inspiratory time(Ti); total duty cycle(Ttot)
oxygen saturation(SpO2)
Heart Rate(HR)
the total recovery time
mouth pressure(Pmo)
Full Information
NCT ID
NCT02012101
First Posted
December 8, 2013
Last Updated
June 23, 2014
Sponsor
Guangzhou Institute of Respiratory Disease
1. Study Identification
Unique Protocol Identification Number
NCT02012101
Brief Title
Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD
Official Title
The Efficacy of Non-invasive Mechanical Ventilation as a Rescue Therapy for Relieving Dyspnea in Patients With Stable Severe COPD
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, dyspnea, exercise, Noninvasive Ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
niv plus oxygen therapy
Arm Type
Experimental
Arm Description
oxygen therapy is given during the whole experimental process, niv is given at peak exercise until the borg scale reaches it's baseline point
Arm Title
oxygen therapy
Arm Type
Active Comparator
Arm Description
oxygen therapy is given during the whole experimental process
Intervention Type
Device
Intervention Name(s)
niv plus oxygen therapy
Other Intervention Name(s)
Philips Respironics BiPAP Vision
Intervention Description
NIV given on Philips Respironics BiPAP Vision apparatus.
Intervention Type
Device
Intervention Name(s)
oxygen therapy
Primary Outcome Measure Information:
Title
Borg scale
Time Frame
baseline,repeated measurement for about ten minutes after intervention
Secondary Outcome Measure Information:
Title
Inspiratory capacity(IC)
Time Frame
baseline,repeated measurement for about ten minutes after intervention
Title
surface electromyography(sEMG)
Time Frame
baseline,repeated measurement for about ten minutes after intervention
Title
respiratory parameters
Description
minute ventilation(VE); tidal volume(Vt); respiratory rate(RR); inspiratory time(Ti); total duty cycle(Ttot)
Time Frame
baseline,repeated measurement for about ten minutes after intervention
Title
oxygen saturation(SpO2)
Time Frame
baseline,repeated measurement for about ten minutes after intervention
Title
Heart Rate(HR)
Time Frame
baseline,repeated measurement for about ten minutes after intervention
Title
the total recovery time
Time Frame
repeated measurement for about ten minutes after intervention
Title
mouth pressure(Pmo)
Time Frame
baseline,repeated measurement for about ten minutes after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rongchang Chen, M.D.
Organizational Affiliation
Sate Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Key Laboratory of Respiratory Disease, First Affiliated Hospital of Guangzhou Medical College
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Mechanical Ventilation as a Rescue Therapy to Relieve Dyspnea in Patients With Stable Severe COPD
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