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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
incremental pressure support
Sponsored by
Zhujiang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Non-invasive Positive Pressure Ventilation, Respiratory Mechanics, Neural Respiratory Drive

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhujiang Hospital,Southern Medical UniversicityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

COPD Group

Arm Description

incremental pressure support

Outcomes

Primary Outcome Measures

Diaphragmatic function
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 Outcome Measures

Respiratory pressure
Respiratory pressure can be assessed by transdiaphragmatic pressure (Pdi).
Respiratory volume
Respiratory volume can be assessed by Tidal volume (VT).
Degree of dyspnea
Difference in the degree of dyspnea can be measured by Borg index.

Full Information

First Posted
May 31, 2018
Last Updated
October 7, 2018
Sponsor
Zhujiang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03555097
Brief Title
Effects of Non-invasive Ventilation on Respiratory Mechanics and NRD in Patients With Stable COPD
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 10, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Non-invasive Positive Pressure Ventilation, Respiratory Mechanics, Neural Respiratory Drive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
COPD Group
Arm Type
Experimental
Arm Description
incremental pressure support
Intervention Type
Procedure
Intervention Name(s)
incremental pressure support
Intervention Description
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 Outcome Measure Information:
Title
Diaphragmatic function
Description
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.
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)
Secondary Outcome Measure Information:
Title
Respiratory pressure
Description
Respiratory pressure can be assessed by transdiaphragmatic pressure (Pdi).
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)
Title
Respiratory volume
Description
Respiratory volume can be assessed by Tidal volume (VT).
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)
Title
Degree of dyspnea
Description
Difference in the degree of dyspnea can be measured by Borg index.
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)
Other Pre-specified Outcome Measures:
Title
Pulse oxygen saturation (SpO2)
Description
Change in SpO2 can be recorded by noninvasive monitoring instruments.
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liqing Wang, doctor
Phone
+86-02062782339
Email
wliqing07@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Chen, doctor
Email
chen_xin1020@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin Chen, doctor
Organizational Affiliation
Zhujiang Hospital,Southern Medical Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhujiang Hospital,Southern Medical Universicity
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liqing Wang, Doctor
Phone
+86-02062783391
Email
wliqing07@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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