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Effects of CPAP Level on Respiratory Mechanics and Central Drive in Patients With COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CPAP level
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 (COPD) focused on measuring COPD, CPAP, Central Drive

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients from Zhu jiang Hospital,Southern Medical University
  • Patients aged 40-70 years old
  • Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% and 30% ≤ FEV1%pred < 80%
  • Patients in a clinically stable state
  • Patients who signed informed consent.

Exclusion Criteria:

  • Patients with signs of an airway infection
  • Patients with an acute exacerbation during the previous 4 weeks
  • Patients with giant bulla(≥3cm in diameter)
  • Patients with recent upper abdominal surgery
  • Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index>15/hr), neuromuscular disease, or significant heart failure
  • Patients with poor compliance.

Sites / Locations

  • Zhujiang Hospital,Southern Medical Universtiy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Moderate COPD patients

Severe COPD patients

Arm Description

Patients are connected to the noninvasive ventilator and incremental CPAP level is performed.

Patients are connected to the noninvasive ventilator and incremental CPAP level is performed.

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 parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).
Respiratory volume
Respiratory volume is associated with Flow, Inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), inspiratory time (Ti),expiratory time (Te), minute ventilation (VE).
Degree of dyspnea
Difference in the degree of dyspnea can be measured by Borg index.

Full Information

First Posted
October 11, 2014
Last Updated
December 29, 2015
Sponsor
Zhujiang Hospital
Collaborators
Guangzhou Institute of Respiratory Disease
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1. Study Identification

Unique Protocol Identification Number
NCT02285400
Brief Title
Effects of CPAP Level on Respiratory Mechanics and Central Drive in Patients With COPD
Official Title
Effects of Continuous Positive Airway Pressure (CPAP) Level on Respiratory Mechanics and Central Drive in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
Collaborators
Guangzhou Institute of Respiratory Disease

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Chronic Obstructive Pulmonary Disease (COPD) is a common respiratory disease characterized by airflow limitation that is progressive and not fully reversible. Expiratory flow limitation (EFL) is the main mechanism leading to dynamic pulmonary hyperinflation (DPH) and intrinsic positive end-expiratory pressure (PEEPi). DPH and PEEPi lead to increased inspiratory muscle efforts and impaired central drive mechanical and ventilation coupling, which is an important mechanism of dyspnea. Appropriate setting of extrinsic PEEP (PEEPe) can decrease inspiratory efforts and work of breathing, improve patient-ventilator synchrony in severe COPD patients with PEEPi and treated with mechanical ventilation. Nevertheless, the effects of CPAP/PEEPe level on respiratory mechanics, especially on central drive mechanical and ventilation coupling, still need further investigations. In the present study, about 40 patients with COPD will be recruited as research subjects. And the investigators aim to observe the changes in respiratory mechanics, central drive mechanics, central drive mechanical and ventilation coupling at different levels of CPAP. Contrast analysis will be conducted to evaluate the effects of CPAP level on respiratory mechanics and central drive during DPH, which may provide a reasonable basis for the clinical application of CPAP to COPD patients and the exploration of a new reasonable CPAP setting method.
Detailed Description
Patients with COPD are divided into two groups: moderate group and severe group, both of which are intervented by CPAP level. The static pressure volume curves of the lung and chest wall (Campbell diagram) were established with slow deep respiratory manoeuvre. Before using CPAP level, we will measure the relevant parameters of lung volume, respiratory flow, diaphragm electromyogram, central drive mechanical and ventilation coupling. Then incremental CPAP level will be applied to investigate the effects of CPAP level on the above mentioned respiratory mechanics parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
COPD, CPAP, Central Drive

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Moderate COPD patients
Arm Type
Experimental
Arm Description
Patients are connected to the noninvasive ventilator and incremental CPAP level is performed.
Arm Title
Severe COPD patients
Arm Type
Experimental
Arm Description
Patients are connected to the noninvasive ventilator and incremental CPAP level is performed.
Intervention Type
Procedure
Intervention Name(s)
CPAP level
Intervention Description
CPAP level ranges between 4 and 12 cm water column (cmH2O), each pressure increment for 1 cmH2O.
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 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Secondary Outcome Measure Information:
Title
Respiratory pressure
Description
Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).
Time Frame
Chang from baseline in respiratory pressure at 12 cmH2O CPAP level.(10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Title
Respiratory volume
Description
Respiratory volume is associated with Flow, Inspiratory capacity (IC), tidal volume (VT), respiratory rate (RR), inspiratory time (Ti),expiratory time (Te), minute ventilation (VE).
Time Frame
Chang from baseline in respiratory volume at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Title
Degree of dyspnea
Description
Difference in the degree of dyspnea can be measured by Borg index.
Time Frame
Chang from baseline in dyspnea at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 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
Chang from baseline in SpO2 at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
Title
End tidal carbon dioxide pressure (PETCO2)
Description
Change in PETCO2 can be recorded by noninvasive monitoring instruments.
Time Frame
Chang from baseline in PETCO2 at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients from Zhu jiang Hospital,Southern Medical University Patients aged 40-70 years old Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% and 30% ≤ FEV1%pred < 80% Patients in a clinically stable state Patients who signed informed consent. Exclusion Criteria: Patients with signs of an airway infection Patients with an acute exacerbation during the previous 4 weeks Patients with giant bulla(≥3cm in diameter) Patients with recent upper abdominal surgery Patients with one or more of the following diseases: esophageal cancer, reflux esophagitis, severe obstructive sleep apnea (apnea hypopnea index>15/hr), neuromuscular disease, or significant heart failure Patients with poor compliance.
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 Universtiy
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510282
Country
China

12. IPD Sharing Statement

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Effects of CPAP Level on Respiratory Mechanics and Central Drive in Patients With COPD

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