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

NCT ID: NCT03555097

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-10
• Study Completion Date: 2019-03-01

Brief Summary

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.

Detailed Description

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.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

COPD Group

incremental pressure support

Group Type: EXPERIMENTAL

incremental pressure support

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Chen, doctor

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital,Southern Medical Unversity

Locations

Zhujiang Hospital,Southern Medical Universicity

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

2018-HXNK-010

Identifier Type: -

Identifier Source: org_study_id