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NCT Number: NCT03555097

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhujiang Hospital,Southern Medical Universicity

Guangzhou, Guangdong, 510282, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

incremental pressure support

Procedure

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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).

  3. 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.

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Registry information

Official study title

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)

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 13, 2018
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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