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NCT Number: NCT02285400

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

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.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, 510282, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CPAP level

Procedure

CPAP level ranges between 4 and 12 cm water column (cmH2O), each pressure increment for 1 cmH2O.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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).

  3. 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Zhujiang Hospital

Other

Collaborators

  • Guangzhou Institute of Respiratory Disease

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 7, 2014
Registry last updated
Dec 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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