Efficacy and Mechanism of NIV in Relieving Dyspnea After Exercise in Patients With Stable Severe COPD
Primary Purpose
Chronic Obstructive Pulmonary Disease, Dyspnea
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
noninvasive ventilation
oxygen therapy
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary 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
- 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
- The First Affiliated Hospital of Guangzhou Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
NIV plus oxygen therapy
oxygen therapy
Arm Description
noninvasive ventilation (dual-limb NIV) is given at peak exercise until the borg scale reaches it's baseline point
oxygen therapy is given at peak exercise until the borg scale reaches it's baseline point
Outcomes
Primary Outcome Measures
change from baseline Borg scale to complete recovery after exercise
this is a scale that asks the participants to rate the difficulty of breathing. It starts at number 0 where one's breathing is causing no difficulty at all and progresses through to number 10 where one's breathing difficulty is maximal.
Secondary Outcome Measures
change from baseline diaphragm electromyogram to complete recovery after exercise
EMGdi
change from baseline index of neuromechanical dissociation of the respiratory system to complete recovery after exercise
EMGdi%max:Vt%VCpred
Full Information
NCT ID
NCT03568747
First Posted
May 30, 2018
Last Updated
July 29, 2019
Sponsor
Guangzhou Institute of Respiratory Disease
1. Study Identification
Unique Protocol Identification Number
NCT03568747
Brief Title
Efficacy and Mechanism of NIV in Relieving Dyspnea After Exercise in Patients With Stable Severe COPD
Official Title
Efficacy and Mechanism of Non-invasive Ventilation in Relieving Dyspnea After Exercise in Patients With Stable Severe Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 23, 2018 (Actual)
Primary Completion Date
February 3, 2019 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangzhou Institute of Respiratory Disease
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Exertional dyspnea is a major cause of exercise limitation and anxiety, and contributes importantly to reduced quality of life for patients with COPD. The aim of this study is to determine the efficacy and mechanism of NIV with a dual-limb circuit plus oxygen therapy in relieving exertional dyspnea in patients with severe COPD, so as to provide a guidance for clinical use for NIV.
Detailed Description
Exertional dyspnea was the most characteristic respiratory symptoms in patients with chronic obstructive pulmonary disease (COPD), it is a major cause of exercise limitation and anxiety, and contributes importantly to reduced quality of life for patients with COPD. 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, which leads to a vicious circle and contribute to the debilitation of the patients. Thereby, intervention should be taken to intervene this vicious cycle. It has been reported that noninvasive ventilation (NIV) could help unload the inspiratory muscle, improve dynamic pulmonary hyperinflation, improve neuro-mechanical coupling, oxygenation, and thus relieved dyspnea during exercise in COPD patients. However, in these reports, NIV was used as add-on therapy during exercise or at resting condition before exertional dyspnea occurred. So far, there's few studies on the efficacy of NIV used at the time of exertional dyspnea occurred as the rescue therapy to relieve dyspnea after exercise in patients with stable severe COPD while the patients are already undergoing optimal treatment with bronchodilator and anti-inflammatory medication, which might relieve their physiological and perceptional burden to limit their activities. The result of the investigators previous study has suggested that compared with oxygen therapy, NIV plus oxygen therapy resulted in decrease in dyspnea intensity at isotime, however, there's no statistically significant shortening in total dyspnea recovery time and NIV was not helpful in all the COPD patients. In another study, it was indicated that ventilated by a single-limb tubing with a plateau exhalation valve (PEV) caused CO2 rebreathing to COPD patients during exercise. CO2 rebreathing may have a negative impact on efficacy. Previous studies have proved that exercise tolerance was improved ventilated by noninvasive ventilation with a dual-limb circuit. In theory, NIV with a dual-limb circuit consists of one inhalation limb that introduces air into the patient's airways and one exhalation limb that leads exhaled gas outside of the airways, there is no risk of rebreathing. However, it is unclear whether NIV with a dual-limb circuit could be used at the time of exertional dyspnea occurred as rescue therapy to relieve dyspnea after exercise in patients with stable severe COPD and what are the mechanisms. The purpose of this study was therefore to determine whether assisted with NIV with dual-limb circuit in patients with stable severe COPD after exercise with exertional dyspnea (1)dyspnea was relieved after exercise in patients with stable severe COPD; (2)the repiratory mechanism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Dyspnea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NIV plus oxygen therapy
Arm Type
Experimental
Arm Description
noninvasive ventilation (dual-limb NIV) is given at peak exercise until the borg scale reaches it's baseline point
Arm Title
oxygen therapy
Arm Type
Experimental
Arm Description
oxygen therapy is given at peak exercise until the borg scale reaches it's baseline point
Intervention Type
Device
Intervention Name(s)
noninvasive ventilation
Intervention Description
dual-limb circuit NIV were given on maquet servo i apparatus
Intervention Type
Device
Intervention Name(s)
oxygen therapy
Intervention Description
oxygen therapy were introduced to the side port of the facemask
Primary Outcome Measure Information:
Title
change from baseline Borg scale to complete recovery after exercise
Description
this is a scale that asks the participants to rate the difficulty of breathing. It starts at number 0 where one's breathing is causing no difficulty at all and progresses through to number 10 where one's breathing difficulty is maximal.
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Secondary Outcome Measure Information:
Title
change from baseline diaphragm electromyogram to complete recovery after exercise
Description
EMGdi
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline index of neuromechanical dissociation of the respiratory system to complete recovery after exercise
Description
EMGdi%max:Vt%VCpred
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Other Pre-specified Outcome Measures:
Title
change from baseline transdiaphragmatic pressure to complete recovery after exercise
Description
Pdi
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline esophageal pressure to complete recovery after exercise
Description
Pes
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline mouth pressure to complete recovery after exercise
Description
Pm
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline inspiratory capacity to complete recovery after exercise
Description
IC
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline minute ventilation to complete recovery after exercise
Description
VE
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline oxygen saturation to complete recovery after exercise
Description
SpO2
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline heart rate to complete recovery after exercise
Description
HR
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline total recovery time to complete recovery after exercise
Description
total recovery time
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline tidal volume to complete recovery after exercise
Description
Vt
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline respiratory rate to complete recovery after exercise
Description
RR
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline inspiratory time to complete recovery after exercise
Description
Ti
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline total duty cycle to complete recovery after exercise
Description
Ttot
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline expiratory time to complete recovery after exercise
Description
Te
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
Title
change from baseline pressure time product to complete recovery after exercise
Description
PTP
Time Frame
baseline, at peak exercise and at every 30s interval until complete recovery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 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
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
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Study Director
Facility Information:
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Mechanism of NIV in Relieving Dyspnea After Exercise in Patients With Stable Severe COPD
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