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

NCT ID: NCT02285400

Last Updated: 2015-12-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2015-12-31

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; CPAP; Central Drive

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Moderate COPD patients

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

Group Type: EXPERIMENTAL

CPAP level

Intervention Type: PROCEDURE

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

Severe COPD patients

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

Group Type: EXPERIMENTAL

CPAP level

Intervention Type: PROCEDURE

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

Interventions

CPAP level

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

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Guangzhou Institute of Respiratory Disease

OTHER

Sponsor Role: collaborator

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xin Chen, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital,Southern Medical Unversity

Locations

Zhujiang Hospital,Southern Medical Universtiy

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

LY20140927

Identifier Type: -

Identifier Source: org_study_id