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

December 29, 2015 updated by: Zhujiang Hospital

Effects of Continuous Positive Airway Pressure (CPAP) Level on Respiratory Mechanics and Central Drive in Patients With Chronic Obstructive Pulmonary Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Zhujiang Hospital,Southern Medical Universtiy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change from baseline in diaphragm electromyogram at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Chang from baseline in respiratory pressure at 12 cmH2O CPAP level.(10 minutes later,20minutes later,30 minutes later, 40 minutes later)
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).
Chang from baseline in respiratory volume at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
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.
Chang from baseline in dyspnea at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Chang from baseline in SpO2 at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)
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.
Chang from baseline in PETCO2 at 12 cmH2O CPAP level. (10 minutes later,20minutes later,30 minutes later, 40 minutes later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Collaborators

Guangzhou Institute of Respiratory Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

October 11, 2014

First Submitted That Met QC Criteria

November 6, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Estimate)

December 31, 2015

Last Update Submitted That Met QC Criteria

December 29, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LY20140927

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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