We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02285400
First Posted: November 7, 2014
Last Update Posted: December 31, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Guangzhou Institute of Respiratory Disease
Information provided by (Responsible Party):
Zhujiang Hospital
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease (COPD) Procedure: CPAP level

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Continuous Positive Airway Pressure (CPAP) Level on Respiratory Mechanics and Central Drive in Patients With Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Zhujiang Hospital:

Primary Outcome Measures:
  • Diaphragmatic function [ Time Frame: Change from baseline in diaphragm electromyogram at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 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 Outcome Measures:
  • Respiratory pressure [ Time Frame: Chang from baseline in respiratory pressure at 12 cmH2O CPAP level.(10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    Respiratory pressure parameters include gastric pressure (Pga), esophageal pressure (Pes), transdiaphragmatic pressure ( Pdi), mouth pressure (Pmo).

  • Respiratory volume [ Time Frame: Chang from baseline in respiratory volume at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    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 [ Time Frame: Chang from baseline in dyspnea at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    Difference in the degree of dyspnea can be measured by Borg index.


Other Outcome Measures:
  • Pulse oxygen saturation (SpO2) [ Time Frame: Chang from baseline in SpO2 at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    Change in SpO2 can be recorded by noninvasive monitoring instruments.

  • End tidal carbon dioxide pressure (PETCO2) [ Time Frame: Chang from baseline in PETCO2 at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later) ]
    Change in PETCO2 can be recorded by noninvasive monitoring instruments.


Enrollment: 30
Study Start Date: November 2014
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moderate COPD patients
Patients are connected to the noninvasive ventilator and incremental CPAP level is performed.
Procedure: CPAP level
CPAP level ranges between 4 and 12 cm water column (cmH2O), each pressure increment for 1 cmH2O.
Experimental: Severe COPD patients
Patients are connected to the noninvasive ventilator and incremental CPAP level is performed.
Procedure: CPAP level
CPAP level ranges between 4 and 12 cm water column (cmH2O), each pressure increment for 1 cmH2O.

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02285400


Locations
China, Guangdong
Zhujiang Hospital,Southern Medical Universtiy
Guangzhou, Guangdong, China, 510282
Sponsors and Collaborators
Zhujiang Hospital
Guangzhou Institute of Respiratory Disease
Investigators
Principal Investigator: Xin Chen, Doctor Zhujiang Hospital,Southern Medical Unversity
  More Information

Responsible Party: Zhujiang Hospital
ClinicalTrials.gov Identifier: NCT02285400     History of Changes
Other Study ID Numbers: LY20140927
First Submitted: October 11, 2014
First Posted: November 7, 2014
Last Update Posted: December 31, 2015
Last Verified: July 2015

Keywords provided by Zhujiang Hospital:
COPD
CPAP
Central Drive

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases