Analyse the Correlation Between sEMG and EMGdi

August 31, 2017 updated by: Lin Lin, The First Affiliated Hospital of Guangzhou Medical University

Investigation of the Correlation of Surface Respiratory EMG With Esophageal Diaphragm EMG

The most significant pathophysiology change of COPD patients is persistent incompletely reversible airflow obstruction and increased lung volume. As a result, the work of breathing(WB) and neural respiratory drive (NRD)increased. Noninvasive positive pressure ventilation (NPPV) can reduce the load of respiratory muscles. Detection of NRD can be the index of monitoring for titration of optimal level of ventilator support in the future. As electromyography(EMG) is the most reliable measurement in evaluating NRD that can be used for human. Currently the standard method for evaluation of NRD with EMG is using esophageal multi-paired electrodes catheter(EMGdi) ,it is reliable but invasive .Surface respiratory EMG (sEMG）is a noninvasive measurement. Although it subjected to contamination and less sensitive, recently, advance in technology with multiple pair of surface electrodes is possible to sufficient signals for evaluation of NRD.So the investigator compare the NRD measured by EMGdi and sEMG,and consider that the correlation between them is well in different levels.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The most significant pathophysiology change of COPD patients is persistent incompletely reversible airflow obstruction and increased lung volume. As a result, the work of breathing (WB) and neural respiratory drive (NRD) increased. Noninvasive positive pressure ventilation (NPPV) is the first-line treatment in acute exacerbation of COPD (AECOPD). One of the mechanisms is to reduce the load of respiratory muscles. It has been reported that NRD decreased in response to increase of pressure support. Detection of NRD can be the index of monitoring for titration of optimal level of ventilator support in the future.

NRD can be measured with minute ventilation, inspiratory pressure change、mean inspiration flow and electromyography(EMG) of inspiratory muscles. However, the first three methods are subjected to the influenced of lung volume, airway resistance and compliance of respiratory system. So, electromyography is the most reliable measurement in evaluating NRD that can be used for human. Currently the standard method for evaluation of NRD with EMG is using esophageal multi-paired electrodes catheter ,since it is far away from chest wall and close to diaphragm , so the contamination from other respiratory muscles can be reduced .However, catheter placement into esophagus is necessary for this measurement, which limits its use in daily practice. Surface respiratory EMG is a noninvasive measurement. Although it subjected to contamination and less sensitive, recent advance in technology with multiple pair of surface electrodes, including surface diaphragm EMG、parasternal EMG and so on, it is possible to sufficient signals for evaluation of NRD. It has been the hot topics of research recently due to its noninvasive, easiness of use and appropriate for continuing monitor.

Purpose：

  1. To explore the feasibility of surface respiratory electromyography and its correlation with esophageal EMG in conditions of different level of respiratory central drive.
  2. To investigate the dynamic change esophageal EMG and surface EMG in response to increase of pressure support level during noninvasive ventilation, in order to evaluate the feasibility of using surface EMG for titration of pressure support during noninvasive ventilation.

Methodology:

  1. Electromyography: Multi-paired electrodes esophageal catheter was used for detection of esophageal diaphragm electromyography (EMGdi); Surface electrodes for left and right diaphragm and parasternal muscle were used to detect surface electromyography (sEMG).
  2. Monitoring of respiratory physiology parameters: Pneumotachometer and differential pressure transducer were used for measurement of respiratory flow and pressures. lung volume change was calculated with integration of flow.
  3. Regulate neural respiratory drive:1.in normal volunteer,increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive;2.in sever COPD patients,increase the pressure support ventilation step by step, in order to decrease neural respiratory drive.
  4. Methods for adjustment of respiratory central drive: (1) The increase of respiratory central drive was induced by inspiratory threshold load step by step (30%-80%MIP) in normal volunteer. (2) The reduction of respiratory central drive was induced by stepwise increase of pressure support level with noninvasive ventilation in COPD patients.

Analysis and statistics:

  1. The correlation between sEMG and EMGdi at different level of respiratory central drive was analyzed with Pearson correlation analysis. The change of Ventilation central drive coupling was calculated.
  2. In COPD patients, the change of respiratory central drive in response to increase of pressure support level (IPAP increase from 8cmH2O to 20cmH2O) during NPPV was evaluated.
  3. The feasibility using sEMG as guidance for adjustment of pressure support level during NPPV was analyzed.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

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

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • normal cardio-pulmonary function
  • without low inspiratory muscle strength
  • non-smoker
  • without history of the nervous system and respiratory system disease
  • sever to very severe stable stage

Exclusion Criteria:

  • systemic application of corticosteroids nearly 4 weeks

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: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Healthy Subjects
increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive.
Device: inspiratory threshold load device and NPPV

before experiment ,every subject use a flanged mouthpiece attached to a manually operated occlusion valve in order to measure maximal inspiratory pressure (MIP)at functional residual capacity .

healthy subjects:increase the pressure in a water-sealed inspiratory threshold loading device in order to increase the neural respiratory drive.

COPD patients:increase the pressure in a non-invasive positive pressure ventilation in order to decrease the neural respiratory drive
EXPERIMENTAL: Sever COPD Patients
increase the pressure support ventilation step by step, in order to decrease neural respiratory drive.
Device: inspiratory threshold load device and NPPV

before experiment ,every subject use a flanged mouthpiece attached to a manually operated occlusion valve in order to measure maximal inspiratory pressure (MIP)at functional residual capacity .

healthy subjects:increase the pressure in a water-sealed inspiratory threshold loading device in order to increase the neural respiratory drive.

COPD patients:increase the pressure in a non-invasive positive pressure ventilation in order to decrease the neural respiratory drive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
correlation between sEMG and EMGdi
Time Frame: through study completion, an average of 5 hours
the correlation between sEMG and EMGdi at different level of respiratory central drive was analyzed with Pearson correlation analysis
through study completion, an average of 5 hours

Collaborators and Investigators

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

Sponsor

The First Affiliated Hospital of Guangzhou Medical University

Investigators

  • Principal Investigator: Rongchang Chen, professor, The first Affiliated Hospital of Guangzhou Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

March 7, 2017

Study Completion (ACTUAL)

July 2, 2017

Study Registration Dates

First Submitted

August 24, 2017

First Submitted That Met QC Criteria

August 29, 2017

First Posted (ACTUAL)

August 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 31, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 487201278

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on COPD

Clinical Trials on inspiratory threshold load device and NPPV

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahamas

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe