An interventional study of dual-limb NIV in Chronic Obstructive Pulmonary Disease, sponsored by Guangzhou Institute of Respiratory Disease. Completed at 1 site in China. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-07-30.
Sponsored by Guangzhou Institute of Respiratory Disease · Not applicable, Interventional, and Treatment
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).
Exercise training is a key component of pulmonary rehabilitation. It has shown signifcant improvements in both exercise tolerance and quality of life in patients with COPD. The intensity of exercise training is of great importance to yield a true physiologic effect. However, in patients with severe COPD, exertional dyspnea and leg fatigue make it impossible for the patient to maintain intensity of training for enough time to achieve a physiologic training effect. NIV has been reported to be used as support for exercise to improve exercise tolerance and respiratory performances in patients with mild-to-severe COPD with inconsistent results. Evidence from previous studies have suggested that NIV with a single-limb circuit with Whisper Swivel II expiratory valve or Plateau exhalation valve assisted during exercise in patients with COPD caused CO2 rebreathing. CO2 rebreathing may have a negative impact on efficacy. Previous studies have proved that exercise tolerance was improved ventilated by NIV 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, there was no report on whether there's no risk of rebreathing in COPD patients ventilated during exercise by a dual-limb circuit. Therefore, the aim of the study was to determine whether there was no CO2 rebreathing occurred assisted with NIV with dual-limb circuit in patients with stable severe COPD after exercise with exertional dyspnea.
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This study's enrollment of 8 is below the median of 66 across 1,837 interventional studies indexed under Lung Diseases, Obstructive.
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Exclusion Criteria:
A maximal cycle exercise test with the participants assisted by BiPAP (Servo i, Maquet, Siemens) receiving 10 cmH2O pressure support in addition to oxygen therapy. During the test, breathing pattern, inspiratory flow of the inhalation limb and expiratory flow of the exhalation limb, fractional concentration of inspired CO2 (FiCO2) of the inspiratory line was measured for each breath were recorded.
Device: dual-limb NIV
dual-limb NIV was served with servo i ventilator
fractional concentration of inspired CO2
FiCO2
Time frame: 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.
inspiratory flow of the inhalation limb
Vti/Ti
Time frame: 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.
expiratory flow of the exhalation limb
Vte/Te
Time frame: 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.
breathing pattern
Ti、Te、Ti/Ttot、RR
Time frame: 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.
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Guangzhou Institute of Respiratory Disease