Respiratory Disease Clinical Trial
Official title:
Correlation and Compatibility Between Surface Respiratory Electromyography and Transesophageal Diaphragmatic Electromyography Measurements During Treadmill Exercise in Stable Patients With COPD
To evaluate the compatibility and correlation between noninvasive surface respiratory electromyography and invasive transesophageal diaphragmatic electromyography measurements, as facilitating indicators of neural respiratory drive evaluation during treadmill exercise. Transesophageal diaphragmatic EMG (EMGdi,es) and surface inspiratory EMG, including surface diaphragmatic EMG (EMGdi,sur), surface parasternal intercostal muscle EMG (EMGpara) and surface sternocleidomastoid EMG (EMGsc) were detected simultaneously during increasing capacity exercise in stable patients with COPD. EMGdi,es, EMGdi,sur, EMGpara and EMGsc was quantified using root mean square (RMS), which represent as RMSdi,es, RMSdi,sur, RMSpara and RMSsc.
Subjects This self-matching clinical trial included twenty patients with COPD (age range,
40-80 years) treated at outpatient respiratory medicine departments at the First Affiliated
Hospital of Guangzhou Medical University between July 2016 and December 2016. The diagnosis
of COPD in all participants were measured using the pulmonary spirometry, according to the
Global Initiative for Chronic Obstructive Lung Disease (GOLD).1 Inclusion criteria: 1) post
bronchodilator forced expiratory volume in 1 s [FEV1]/forced vital capacity [FVC] ,70% and
FEV1 ,50% of the predicted value); 2) bronchial dilation test (BDT) negative. Exclusion
criteria: 1) acute exacerbation in the previous 4 weeks; 2) use of oral corticosteroids
within 4 weeks; and 3) smoking more than 10 cigarettes daily; (4) history of other
respiratory, cardiovascular, neuromuscular, and musculoskeletal diseases that could interfere
with the exercise performance and inspiratory muscle activities.
Study design This study has been reviewed and published on the ClinicalTrials.gov public site
(identifier: NCT03017300, Clinical trial date of registration: March 29, 2017). The study
protocol was approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou
Medical University. Informed consent was obtained from COPD patients before participation in
this study. To ensure the rights of all participants were protected, the researchers strictly
adhered to the Declaration of Helsinki and the ethical principles in designing and conducting
clinical research.
Measurements of transesophageal diaphragmatic EMG (EMGdi,es) EMGdi,es is the classic
representative index describing activity of diaphragmatic myoelectric signals, the electrical
manifestations of the excitation process elicited by action potentials propagating along
muscle fiber membranes. The EMG signal is detected with multiple electrodes and then
amplified, filtered, and displayed on a screen or digitized to facilitate further analysis.
Electromyography of respiratory muscles can be used to assess the level and pattern of their
activation so as to detect and diagnose neuromuscular pathology and, when coupled with tests
of mechanical function, to assess the efficacy of the muscle's contractile function. Neural
respiratory drive, expressed as EMGdi, was measured using a multipair esophageal electrode
consisting of nine consecutive coils composed of five electrode pairs positioned in the
esophagus and traversing the cardia. EMGdi signals acquired with digital sampling at 2 kHz
were bandpass filtered (10 Hz-3 kHz) and amplified. Peak RMS per respiratory cycle was
calculated and averaged over 1 min. RMS of the EMGdi signal is thequantification of the total
EMGdi power. Theoretically, the RMS of the EMGdi reflects the force output from the brainstem
respiratory centre to the peripheral respiratory muscles and also reflect the sensation of
dyspnea.
Measurements of surface inspiratory EMG EMG electrodes The electrical activity of the surface
inspiratory EMG was derived transcutaneously from pairs of single disposable electrodes
(Neotrode, Conmed Corporation, New York, USA). For the commonor ground electrode the same
disposable electrode was used. Electrical activity of the sternocleidomastoidmuscles and
Intercostals muscles were derived transcutaneously from reusablebipolar electrodes formed by
two narrow rim electrodes housings, each containing a 4mm Ag-AgCl sintered electrode pallet
(InVivo Metrics, Healdsburg, USA), interconnected with a plastic clip (homemade UMCG,
Groningen, The Netherlands) at a distance of14mm. After filling the electrode cavity with
electrode gelthe assembly was fixed to the skin by means of double sided adhesives. All EMG
signals detected by electrodes were convey to connected to the biological signal acquisition
and analysis system (Powerlab 16/35; ADInstruments) by shielded low noise cables.
Electrode placement Surface diaphragmatic EMG (EMGdi,sur): The surface detecting electrode
couple were separately placed at the intersection point of the sixth and eight intercostal
space and anterior axillary line, at a distance of 5 cm.10 Surface parasternal EMG (EMGpara):
The surface detecting electrodes were placed bilaterally in the second intercostal space,
about 3 cm parasternal, a reference ground electrode was placed atthe sternum sternal angle.
Surface sternocleidomastoid EMG (EMGsc): Surface detecting electrode were placed on the 1/3
and 2/3 of overall length of sternocleidomastoid, a reference ground electrode was placed at
the suprasternal fossa.
Exercise testing All subjects performed a maximal incremental cycle ergometry test in a
sitting posture, in order to minimize the effects of muscle activity necessary for body
stabilization (Ergoselect 200 K; Cosmed, Rome, Italy). Furthermore, to minimize muscle
activity for head positioning, the subjects were instructed to look straight ahead during the
measurements. The test consisted of a steady-state resting period of 3 min followed by 1 min
of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by
10 W each min until the test had to be stopped because symptoms prevented further exercise.
After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal
exercise capacity were analysed.
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