COPDNCT03268616
Analyse the Correlation Between sEMG and EMGdi
A study testing inspiratory threshold load device and NPPV in people with COPD, run by The First Affiliated Hospital of Guangzhou Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- inspiratory threshold load device and NPPV
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 2 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- systemic application of corticosteroids nearly 4 weeks
About this study
Official title: 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.
Read the 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：
- To explore the feasibility of surface respiratory electromyography and its correlation with esophageal EMG in conditions of different level of respiratory central drive.
- 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:
- 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).
- 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.
- 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.
- 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:
- 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.
- 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.
- The feasibility using sEMG as guidance for adjustment of pressure support level during NPPV was analyzed.
- Conditions
- COPD
- Being tested
- inspiratory threshold load device and NPPV
- Keywords
- neural respiratory drive, noninvasive positive pressure ventilation, electromyography
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inspiratory threshold load device and NPPVDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Healthy Subjects | Experimental | increase the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. Receives: Device: inspiratory threshold load device and NPPV |
| Sever COPD Patients | Experimental | increase the pressure support ventilation step by step, in order to decrease neural respiratory drive. Receives: Device: inspiratory threshold load device and NPPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between sEMG and EMGdi
the correlation between sEMG and EMGdi at different level of respiratory central drive was analyzed with Pearson correlation analysis
Measured: through study completion, an average of 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start1 Sep 2016
- Primary completion7 Mar 2017
- Study completion2 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lin Lin, The First Affiliated Hospital of Guangzhou Medical University
- Investigators
- Rongchang Chen, professor, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268616
- Sponsor's protocol ID
- 487201278
- Status last verified
- Aug 2017
- First submitted
- 24 Aug 2017
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Whitelaw WA, Derenne JP. Airway occlusion pressure. J Appl Physiol (1985). 1993 Apr;74(4):1475-83. doi: 10.1152/jappl.1993.74.4.1475.
PubMed 8514660Luo YM, Moxham J, Polkey MI. Diaphragm electromyography using an oesophageal catheter: current concepts. Clin Sci (Lond). 2008 Oct;115(8):233-44. doi: 10.1042/CS20070348.
PubMed 18782085Reilly CC, Ward K, Jolley CJ, Lunt AC, Steier J, Elston C, Polkey MI, Rafferty GF, Moxham J. Neural respiratory drive, pulmonary mechanics and breathlessness in patients with cystic fibrosis. Thorax. 2011 Mar;66(3):240-6. doi: 10.1136/thx.2010.142646. Epub 2011 Feb 1.
PubMed 21285244Laghi F, Shaikh HS, Morales D, Sinderby C, Jubran A, Tobin MJ. Diaphragmatic neuromechanical coupling and mechanisms of hypercapnia during inspiratory loading. Respir Physiol Neurobiol. 2014 Jul 1;198:32-41. doi: 10.1016/j.resp.2014.03.004. Epub 2014 Apr 16.
PubMed 24747754American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
PubMed 12186831Wanke T, Lahrmann H, Formanek D, Zwick H. Effect of posture on inspiratory muscle electromyogram response to hypercapnia. Eur J Appl Physiol Occup Physiol. 1992;64(3):266-71. doi: 10.1007/BF00626290.
PubMed 1563372Jolley CJ, Luo YM, Steier J, Reilly C, Seymour J, Lunt A, Ward K, Rafferty GF, Polkey MI, Moxham J. Neural respiratory drive in healthy subjects and in COPD. Eur Respir J. 2009 Feb;33(2):289-97. doi: 10.1183/09031936.00093408. Epub 2008 Oct 1.
PubMed 18829678Li Y, Li YH, Li S, Luo YW, Xiao R, Huang YX, Huang JL, Chen YT, Zhi RC, Chen X. Efficiency of neural respiratory drive for the assessment of bronchodilator responsiveness in patients with chronic obstructive pulmonary disease: an exploratory study. J Thorac Dis. 2016 May;8(5):958-65. doi: 10.21037/jtd.2016.03.70.
PubMed 27162672Murphy PB, Kumar A, Reilly C, Jolley C, Walterspacher S, Fedele F, Hopkinson NS, Man WD, Polkey MI, Moxham J, Hart N. Neural respiratory drive as a physiological biomarker to monitor change during acute exacerbations of COPD. Thorax. 2011 Jul;66(7):602-8. doi: 10.1136/thx.2010.151332. Epub 2011 May 19.
PubMed 21597112Suh ES, Mandal S, Harding R, Ramsay M, Kamalanathan M, Henderson K, O'Kane K, Douiri A, Hopkinson NS, Polkey MI, Rafferty G, Murphy PB, Moxham J, Hart N. Neural respiratory drive predicts clinical deterioration and safe discharge in exacerbations of COPD. Thorax. 2015 Dec;70(12):1123-30. doi: 10.1136/thoraxjnl-2015-207188. Epub 2015 Jul 20.
PubMed 26194996Jensen D, O'Donnell DE, Li R, Luo YM. Effects of dead space loading on neuro-muscular and neuro-ventilatory coupling of the respiratory system during exercise in healthy adults: implications for dyspnea and exercise tolerance. Respir Physiol Neurobiol. 2011 Dec 15;179(2-3):219-26. doi: 10.1016/j.resp.2011.08.009. Epub 2011 Aug 22.
PubMed 21888993Duiverman ML, van Eykern LA, Vennik PW, Koeter GH, Maarsingh EJ, Wijkstra PJ. Reproducibility and responsiveness of a noninvasive EMG technique of the respiratory muscles in COPD patients and in healthy subjects. J Appl Physiol (1985). 2004 May;96(5):1723-9. doi: 10.1152/japplphysiol.00914.2003. Epub 2003 Dec 5.
PubMed 14660508Maarsingh EJ, van Eykern LA, Sprikkelman AB, Hoekstra MO, van Aalderen WM. Respiratory muscle activity measured with a noninvasive EMG technique: technical aspects and reproducibility. J Appl Physiol (1985). 2000 Jun;88(6):1955-61. doi: 10.1152/jappl.2000.88.6.1955.
PubMed 10846005Nava S, Ambrosino N, Rubini F, Fracchia C, Rampulla C, Torri G, Calderini E. Effect of nasal pressure support ventilation and external PEEP on diaphragmatic activity in patients with severe stable COPD. Chest. 1993 Jan;103(1):143-50. doi: 10.1378/chest.103.1.143.
PubMed 8417869Reilly CC, Jolley CJ, Ward K, MacBean V, Moxham J, Rafferty GF. Neural respiratory drive measured during inspiratory threshold loading and acute hypercapnia in healthy individuals. Exp Physiol. 2013 Jul;98(7):1190-8. doi: 10.1113/expphysiol.2012.071415. Epub 2013 Mar 15.
PubMed 23504646
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Correlation of Surface Respiratory EMG With Esophageal Diaphragm EMG
- ClinicalTrials.gov ID
- NCT03268616
- Acronym / sponsor ID
- 487201278
- Conditions
- COPD
- Keywords
- neural respiratory drive, noninvasive positive pressure ventilation, electromyography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 7 Mar 2017 (actual)
- Study completion
- 2 Jul 2017 (actual)
- First posted
- 31 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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：
- To explore the feasibility of surface respiratory electromyography and its correlation with esophageal EMG in conditions of different level of respiratory central drive.
- 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:
- 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).
- 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.
- 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.
- 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:
- 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.
- 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.
- The feasibility using sEMG as guidance for adjustment of pressure support level during NPPV was analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Subjects | Experimental | Device: inspiratory threshold load device and NPPVincrease the inspiratory threshold load step by step(30%-80%MIP),in order to increase neural respiratory drive. |
| Sever COPD Patients | Experimental | Device: inspiratory threshold load device and NPPVincrease the pressure support ventilation step by step, in order to decrease neural respiratory drive. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- systemic application of corticosteroids nearly 4 weeks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| inspiratory threshold load device and NPPVbefore 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 | Device | Healthy Subjects, Sever COPD Patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 8514660Whitelaw WA, Derenne JP. Airway occlusion pressure. J Appl Physiol (1985). 1993 Apr;74(4):1475-83. doi: 10.1152/jappl.1993.74.4.1475.
- Background: PubMed 18782085Luo YM, Moxham J, Polkey MI. Diaphragm electromyography using an oesophageal catheter: current concepts. Clin Sci (Lond). 2008 Oct;115(8):233-44. doi: 10.1042/CS20070348.
- Background: PubMed 21285244Reilly CC, Ward K, Jolley CJ, Lunt AC, Steier J, Elston C, Polkey MI, Rafferty GF, Moxham J. Neural respiratory drive, pulmonary mechanics and breathlessness in patients with cystic fibrosis. Thorax. 2011 Mar;66(3):240-6. doi: 10.1136/thx.2010.142646. Epub 2011 Feb 1.
- Background: PubMed 24747754Laghi F, Shaikh HS, Morales D, Sinderby C, Jubran A, Tobin MJ. Diaphragmatic neuromechanical coupling and mechanisms of hypercapnia during inspiratory loading. Respir Physiol Neurobiol. 2014 Jul 1;198:32-41. doi: 10.1016/j.resp.2014.03.004. Epub 2014 Apr 16.
- Background: PubMed 12186831American Thoracic Society/European Respiratory Society. ATS/ERS Statement on respiratory muscle testing. Am J Respir Crit Care Med. 2002 Aug 15;166(4):518-624. doi: 10.1164/rccm.166.4.518. No abstract available.
- Background: PubMed 1563372Wanke T, Lahrmann H, Formanek D, Zwick H. Effect of posture on inspiratory muscle electromyogram response to hypercapnia. Eur J Appl Physiol Occup Physiol. 1992;64(3):266-71. doi: 10.1007/BF00626290.
- Results publication: PubMed 18829678Jolley CJ, Luo YM, Steier J, Reilly C, Seymour J, Lunt A, Ward K, Rafferty GF, Polkey MI, Moxham J. Neural respiratory drive in healthy subjects and in COPD. Eur Respir J. 2009 Feb;33(2):289-97. doi: 10.1183/09031936.00093408. Epub 2008 Oct 1.
- Results publication: PubMed 27162672Li Y, Li YH, Li S, Luo YW, Xiao R, Huang YX, Huang JL, Chen YT, Zhi RC, Chen X. Efficiency of neural respiratory drive for the assessment of bronchodilator responsiveness in patients with chronic obstructive pulmonary disease: an exploratory study. J Thorac Dis. 2016 May;8(5):958-65. doi: 10.21037/jtd.2016.03.70.
- Results publication: PubMed 21597112Murphy PB, Kumar A, Reilly C, Jolley C, Walterspacher S, Fedele F, Hopkinson NS, Man WD, Polkey MI, Moxham J, Hart N. Neural respiratory drive as a physiological biomarker to monitor change during acute exacerbations of COPD. Thorax. 2011 Jul;66(7):602-8. doi: 10.1136/thx.2010.151332. Epub 2011 May 19.
- Results publication: PubMed 26194996Suh ES, Mandal S, Harding R, Ramsay M, Kamalanathan M, Henderson K, O'Kane K, Douiri A, Hopkinson NS, Polkey MI, Rafferty G, Murphy PB, Moxham J, Hart N. Neural respiratory drive predicts clinical deterioration and safe discharge in exacerbations of COPD. Thorax. 2015 Dec;70(12):1123-30. doi: 10.1136/thoraxjnl-2015-207188. Epub 2015 Jul 20.
- Results publication: PubMed 21888993Jensen D, O'Donnell DE, Li R, Luo YM. Effects of dead space loading on neuro-muscular and neuro-ventilatory coupling of the respiratory system during exercise in healthy adults: implications for dyspnea and exercise tolerance. Respir Physiol Neurobiol. 2011 Dec 15;179(2-3):219-26. doi: 10.1016/j.resp.2011.08.009. Epub 2011 Aug 22.
- Results publication: PubMed 14660508Duiverman ML, van Eykern LA, Vennik PW, Koeter GH, Maarsingh EJ, Wijkstra PJ. Reproducibility and responsiveness of a noninvasive EMG technique of the respiratory muscles in COPD patients and in healthy subjects. J Appl Physiol (1985). 2004 May;96(5):1723-9. doi: 10.1152/japplphysiol.00914.2003. Epub 2003 Dec 5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rongchang Chen, professor principal investigator
The First Affiliated Hospital of Guangzhou Medical University
Questions about this trial
What is this clinical trial studying?
A study testing inspiratory threshold load device and NPPV in people with COPD, run by The First Affiliated Hospital of Guangzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between sEMG and EMGdi (time frame: through study completion, an average of 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268616, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.