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Effects of Non-invasive Ventilation on Respiratory Mechanics and NRD in Patients With Stable COPD

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ClinicalTrials.gov Identifier: NCT03555097
Recruitment Status : Not yet recruiting
First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Zhujiang Hospital

May 31, 2018
June 13, 2018
June 13, 2018
July 1, 2018
January 1, 2019   (Final data collection date for primary outcome measure)
Diaphragmatic function [ Time Frame: Change from baseline in diaphragm electromyogram at the pressure of 10cm water column (cmH2O). (5minutes later, 10 minutes later, 15 minutes later, 20 minutes later, 25 minutes later, 30 minutes later, 35 minutes later) ]
Diaphragmatic function can be assessed by diaphragm electromyogram (EMGdi), which reflect the physiological activity of the diaphragm and indicate functional status of the central drive.
Same as current
No Changes Posted
  • Respiratory pressure [ Time Frame: Change from baseline in diaphragm electromyogram at the pressure of 10cm water column (cmH2O). (5minutes later, 10 minutes later, 15 minutes later, 20 minutes later, 25 minutes later, 30 minutes later, 35 minutes later) ]
    Respiratory pressure can be assessed by transdiaphragmatic pressure (Pdi).
  • Respiratory volume [ Time Frame: Change from baseline in diaphragm electromyogram at the pressure of 10cm water column (cmH2O). (5minutes later, 10 minutes later, 15 minutes later, 20 minutes later, 25 minutes later, 30 minutes later, 35 minutes later) ]
    Respiratory volume can be assessed by Tidal volume (VT).
  • Degree of dyspnea [ Time Frame: Change from baseline in diaphragm electromyogram at the pressure of 10cm water column (cmH2O). (5minutes later, 10 minutes later, 15 minutes later, 20 minutes later, 25 minutes later, 30 minutes later, 35 minutes later) ]
    Difference in the degree of dyspnea can be measured by Borg index.
Same as current
Pulse oxygen saturation (SpO2) [ Time Frame: Change from baseline in diaphragm electromyogram at the pressure of 10cm water column (cmH2O). (5minutes later, 10 minutes later, 15 minutes later, 20 minutes later, 25 minutes later, 30 minutes later, 35 minutes later) ]
Change in SpO2 can be recorded by noninvasive monitoring instruments.
Same as current
 
Effects of Non-invasive Ventilation on Respiratory Mechanics and NRD in Patients With Stable COPD
Effects of Non-invasive Positive Pressure Ventilation at Different Pressure on Respiratory Mechanics and Neural Respiratory Drive(NRD)in Patients With Stable Chronic Obstructive Pulmonary Disease(COPD)
Chronic obstructive pulmonary disease (COPD) is a chronic respiratory disease characterized by persistent respiratory symptoms and airflow limitation. Pervasive dynamic pulmonary hyperinflation (DPH) and intrinsic positive end-expiratory pressure (PEEPi) can increase inspiratory threshold load and respiratory effort, leading to abnormal changes in respiratory mechanics and neural respiratory drive (NRD). Non-invasive positive pressure ventilation (NPPV) is not only widely used in respiratory failure, but also is one of the important lung rehabilitation strategies. Several studies have reported that the use of biphasic positive airway pressure (BIPAP) mode for NPPV can improve ventilation, reduce NRD, improve NRD coupling, significantly reduce inspiratory muscle load and relieve symptoms. However, relatively few studies are reported that the NPPV is used in COPD patients without non-respiratory failure. Therefore, we suppose that for stable COPD patients without respiratory failure, early intervention with NPPV may reduce DPH, eliminate the adverse effects of PEEPi, reduce the respiratory muscle load, improve the respiratory physiological characteristics, and delay the progression of the disease. Therefore, the purpose of this study is to observe the influence of different levels of BIPAP ventilation on respiratory mechanics and NRD in patients with stable COPD, and to explore whether BiPAP ventilation can be used as a pulmonary rehabilitation method for early intervention of COPD and provide a theoretical basis for subsequent clinical trials.
The patients with COPD will be admitted in one intervention groups. Before using BiPAP ventilation, we will measure the relevant parameters of lung volume, respiratory flow, diaphragm electromyogram, neural respiratory drive mechanical and other baseline index. Then incremental pressure support will be applied to investigate the effects of different levels of BIPAP ventilation on respiratory mechanics and neural respiratory drive.
Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
Procedure: incremental pressure support
Inspiratory positive airway pressure (IPAP) gradually increases from 10 to 24 cm water column (cmH2O) with 2 water column (cmH2O) increments. The expiratory positive airway pressure (EPAP) remains 4 water column (cmH2O), and each pressure level is maintained for 5 to 10 minutes.
Experimental: COPD Group
incremental pressure support
Intervention: Procedure: incremental pressure support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
20
Same as current
March 1, 2019
January 1, 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% after inhalation of bronchial dilation agent. Patients in a clinically stable state.

Exclusion Criteria:

  • Patients they had other respiratory diseases, or evidence of pneumothorax or mediastinal emphysema and pacemaker installed. Patients with acute cardiovascular event and severe cor pulmonale. Patients with poor compliance. An Other causes of diaphragmatic dysfunction.
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Older Adult)
No
Contact: Liqing Wang, doctor +86-02062782339 wliqing07@gmail.com
Contact: Xin Chen, doctor chen_xin1020@163.com
China
 
 
NCT03555097
2018-HXNK-010
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Zhujiang Hospital
Zhujiang Hospital
Not Provided
Principal Investigator: Xin Chen, doctor Zhujiang Hospital,Southern Medical Unversity
Zhujiang Hospital
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP