Acute Effects of Incremental Inspiratory Loads on Respiratory Mechanics and NRD in Patient With Stable COPD.

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Acute Effects of Incremental Inspiratory Loads on Respiratory Mechanics and Neural Respiratory Drive(NRD) in Patient With Stable Chronic Obstructive Pulmonary Disease(COPD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532243
• Other study ID #: 2018-HXNK-007
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: March 2018
• Source: Zhujiang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Inspiratory muscle training has been an important part of pulmonary rehabilitation program directed at patients with COPD. It can increase respiratory muscle strength, relieve dyspnea ,improve the quality of life in COPD patients. However, there is no uniform standard for the intensity of inspiratory muscle training. By comparing a series of indexes, such as maximal inspiratory pressure, maximal expiratory pressure, degree of dyspnea and exercise capacity before and after the training under different intensity, a large number of literatures have explored the appropriate intensity of inspiratory muscle training. But to date, there are few studies about the effects of different intensity of inspiratory muscle training on respiratory physiological mechanism. It has been shown that inspiratory muscle training may be more beneficial to improve the pulmonary rehabilitation effect of COPD patients with inspiratory muscle weakness. So it is not clear whether there is a difference in respiratory physiology between patients with normal inspiratory muscle strength and those with lower inspiratory muscle strength. Respiratory central drive, as an important physiological index, which can be reflected by minute ventilation volume, mouth pressure, mean inspiratory flow and diaphragm electromyography,is closely related to the symptoms and the severity of the disease.Therefore,the purpose of this study was to investigate the changes of respiratory mechanics and central drive in COPD patients at different inspiratory loads, and at the same loads between patients with and without respiratory muscle weakness.That can provide more evidential evidence for setting up the intensity of inspiratory muscle training.

Description:

The patients with COPD will be admitted in one intervention groups(performing on threshold loading device).Before using threshold loading device, we will measure the relevant parameters of lung volume, respiratory flow,diaphragm electromyogram, central drive mechanical and other baseline index.Then incremental inspiratory load will be applied to investigate the effects of inspiratory load on the above mentioned respiratory mechanics parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 1, 2019
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Patients with pulmonary function test of forced expiratory volume at one second (FEV1)/forced vital capacity(FVC) < 70% after inhalation of bronchial dilation agent. Patients in a clinically stable state.

Exclusion Criteria:

• Patients were excluded if they had other respiratory diseases ,or evidence of pneumothorax or mediastinal emphysema and pacemaker installed. Patients with acute cardiovascular event and severe cor pulmonale. Patients with poor compliance. An Other causes of diaphragmatic dysfunction

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Respiratory Aspiration

Intervention

Procedure:
• incremental inspiratory load
inspiratory load ranges between 10 and 40 cm water column (cmH2O)or intolerable to the patient, each load increment for 5cm water column.

Locations

Country	Name	City	State
China	Zhujiang Hospital,Southern Medical Universtiy	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Zhujiang Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pulse oxygen saturation (SpO2)	Change in SpO2 can be recorded by noninvasive monitoring instruments.	Change from baseline in pulse oxygen saturation at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later)
Primary	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.	Change from baseline in diaphragm electromyogram at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later)
Secondary	Respiratory pressure	Respiratory pressure can be assessed by transdiaphragmatic pressure ( Pdi).	Change from baseline in respiratory pressure at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later)
Secondary	Respiratory volume	Respiratory volume can be assessed by Tidal volume (VT).	Change from baseline in respiratory volume at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later)
Secondary	Degree of dyspnea	Difference in the degree of dyspnea can be measured by Borg index.	Change from baseline in degree of dyspnea at the load of 10cm water column (cmH2O).(1 minutes later,3 minutes later,5 minutes later,7 minutes later,9 minutes later,11 minutes later, 13 minutes later)