Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Evaluation of Carbon-dioxide Rebreathing During Exercise With the Increasing Ventilation Assisted by Noninvasive Ventilation With a Dual-limb Circuit
NCT number | NCT03554460 |
Other study ID # | GIRD201802 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 23, 2018 |
Est. completion date | March 31, 2019 |
Verified date | June 2018 |
Source | Guangzhou Institute of Respiratory Disease |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Ventilated by a single-limb tubing with PEV caused CO2 rebreathing to COPD patients during exercise with the increasing ventilation. The aim of this study was to evaluate whether CO2 rebreathing could be avoided with the use of the dual-limb circuit, to provide a theoretical basis of more rational clinical application of NIV in the setting of increasing ventilation(eg, after exercise).
Status | Completed |
Enrollment | 8 |
Est. completion date | March 31, 2019 |
Est. primary completion date | February 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - presented clinically stable (no exacerbation in the 4 weeks prior to study - participation or with no change in medications); - physician diagnosed COPD, forced expiratory volume in 1s (FEV1) < 50% predicted; dyspnea as a main symptom that limited daily activities. Exclusion Criteria: - subjects with obvious pulmonary bullae demonstrated by chest CT scan or X-ray; examination or facial trauma/malformation, recent facial, upper airway or upper gastrointestinal tract surgery, that would preclude receiving NIV therapy; - a history of coronary artery disease or cardiac arrhythmias or potential electrocardiographic alterations; - a history of uncontrolled hypertension, or other respiratory diseases; - patients with musculoskeletal or neurological disorders; - failure to comply with the research protocol. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangzhou Institute of Respiratory Disease |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fractional concentration of inspired CO2 | FiCO2 | Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process. | |
Secondary | inspiratory flow of the inhalation limb | Vti/Ti | Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process. | |
Secondary | expiratory flow of the exhalation limb | Vte/Te | Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process. | |
Secondary | breathing pattern | Ti?Te?Ti/Ttot?RR | Measurements were collected continuously throughout a symptom-limited cycle exercise test (test lasts for about 8-12 min) while subjects breathed through the full face mask. Analyses were made breath by breath during the whole test process. |
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