COPDEMGCOPDNCT02721199
EMG in COPD - Factor Analysis
An observational study of COPD, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Acute exacerbations of COPD contribute to significant morbidity and mortality in the United Kingdom (UK). The ability to assess response to treatment during exacerbations that require hospitalisation would allow clinicians to better risk stratify patients for higher or lower level in-patient or out-patient care. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- COPD
- What is being tested?
- Neural Respiratory Drive Automated EMGpara assessment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Jun 2016
- Phase
- Observational
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to St Thomas' Hospital with a primary diagnosis of an acute exacerbation of COPD.
Who may be able to join
- COPD (as defined by GOLD criteria
- Acute exacerbation of COPD necessitating hospital admission
- Expected to remain an inpatient for ≥ 24 hours
- Able to give informed consent to participation in the study
Who cannot join
- Decompensated respiratory failure (pH < 7.35)
- Significant physical, social or psychiatric factors that would prevent compliance with trial protocol
- Aged < 35 years or aged > 85 years
- Pregnancy
- BMI > 30kg/m2
- Presence of another acute pathology (such as pulmonary embolism or pulmonary oedema) to explain the acute presentation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of Factors Affecting Respiratory Muscle EMG Measurements During Hospital Admission With Acute Exacerbation of COPD
Acute exacerbations of COPD contribute to significant morbidity and mortality in the United Kingdom (UK). The ability to assess response to treatment during exacerbations that require hospitalisation would allow clinicians to better risk stratify patients for higher or lower level in-patient or out-patient care. Current methods of detecting clinical deterioration are validated in general medical populations and may lack sensitivity and specificity in patients with respiratory morbidity. The use of respiratory muscle EMG to assess neural respiratory drive (NRD) has been demonstrated to be a predictor of readmission in patients admitted to hospital with COPD. The technique has been applied on 'spot' readings of limited duration due to the need for hand analysis of the data. It has been performed by a trained clinical physiologist who removed any interference data and standardised the data gathered. New automated software allows for longer periods of observation, mostly unsupervised, and as a result, the NRD measurements are more likely to be affected by various sources of variability. The influence of clinical and physiological factors as they occur during routine clinical management, such as administration of bronchodilator medication, time of day of readings or proximity to chest physiotherapy, are not yet understood. This trial is designed to gather data to better understand these relationships with NRD.
Read the detailed description
Introduction Patients admitted to hospital with acute exacerbations of COPD are at risk of significant in-hospital morbidity and mortality. Current markers of treatment success involve the integration of basic physiological variables (respiratory rate, heart rate, oxygen saturations), clinical examination and patient reported symptoms changes. Whilst the use of these physiological parameters are gold standard there remains concern that patient deterioration is often not detected and escalated effectively. This has led to the development and implementation of a range of clinical physiological composite scores such as the medical early warning score or the National Health Service (NHS) early warning scores. However, these scores have been validated in general rather than specific populations and there are concerns regarding their use in respiratory patient groups.The use of the parasternal intercostal muscle EMG (EMGpara) has been reported to track clinical change and identify treatment failure during hospital admissions with acute exacerbations of COPD (AECOPD) in selected and unselected cohorts. In these pilot works measurements were taken on research equipment and data analysed individually by a trained physiologist. The clinical physiologist ensured standardisation of recording conditions such as proximity to medication, patient position, time of day and recent activity. The effect of such clinical and physiological factors on EMGpara was minimised by the operator with preventive measures, such as the control for the measurement time, the limitation of the recording duration and the exclusion of any artefactual changes in EMGpara. The development of automated software allows for frequent sampling and continuous monitoring, which will potentially permit earlier detection of clinical deterioration. With an automated system however, clinical and physiological factors need to be carefully considered, in particular when the measurement is performed in an unsupervised or less closely supervised environment. This feasibility study is therefore designed to investigate repeatability of EMGpara in hospital-based AECOPD management (i.e. EMGpara changes reflect changes in clinical status). It will give us insight into potential control/mitigation measures and their implementation, in order to ultimately minimise false readings.
Study objectives To investigate the clinical and physiological factors that may affect the measurement of EMGpara in acute setting so as to enhance the clinical effectiveness of EMGpara in identifying treatment failure and clinical deterioration.
- Conditions
- COPD
- Being tested
- Neural Respiratory Drive Automated EMGpara assessment
- 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.
Neural Respiratory Drive Automated EMGpara assessmentOther
Neural respiratory drive will be measured using surface electrodes and nasal cannula . The 2nd intercostal space will be identified by bony landmarks and skin preparation will be performed using detergent wipes, followed by EMG preparation gel with final cleaning to remove exfoliated skin. Wet gel electrodes will be placed immediately adjacent to the sternal border in the 2nd intercostal space and will be connected to the automated EMG analysis system. Electrodes will remain in place for the duration of the study. A nasal cannula will be placed in the nose and detect pressure changes during respiration in order to ensure accurate detection of inspiratory cycle. In addition, an accelerometer will be attached to the thorax of the patient
| Study group | Role | What they receive |
|---|---|---|
| Prospective Cohort | Neural Respiratory Drive Automated EMGpara assessment Receives: Other: Neural Respiratory Drive Automated EMGpara assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting Medication Intake
Noting all medications taken during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting oxygen therapy.
Noting oxygen therapy, if any during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting use of non invasive ventilation.
Noting use of non invasive ventilation, if any during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting intubation details.
Noting details if participant is intubated during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if participant is transferred to critical care.
Noting details if participant is transferred to critical care during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if participant takes part in a respiratory physiotherapy session.
Noting details if participant takes part in a respiratory physiotherapy session during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), physiological factors that change EMG parasternal readings. If participant goes into clinical respiratory deterioration by the need for treatment/care escalation.
Noting details if participant is intubated during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of COPD, the physiological factors that can change EMG parasternal readings. If participant goes into clinical respiratory deterioration National Early Warning Score (NEWS) CREWS
Noting details if participant is documented as being in clinical respiratory deterioration as defined by NEWS/CREWS during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if participant partakes in physical activity
Noting details if participant partakes in any physical activity during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), physiological factors that change EMG parasternal readings. Collecting information when participant sleeps
Noting details when participant sleeps during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if there is any postural change
Noting details if participant changes postural position during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
Measured: 3 days
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if participant takes part in a rehabilitation physiotherapy session.
Noting details if participant takes part in a rehabilitation physiotherapy session during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day
Measured: 3 days
Secondary outcomes (6)
Is it possible to perform Continuous EMGpara acquisition in a clinical setting
Measured: 3 Days
Continuous EMGpara acquisition in clinical setting, is it applicable.
Measured: 3 Days
Continuous EMGpara acquisition in clinical setting, preliminary insights on device requirements for this environment.
Measured: 3 Days
EMGpara trends as it relates to standardly used metrics, e.g. vital signs, patient-reported symptoms.
Measured: 3 Days
Rhe automated neural respiratory drive (NRD) calculation algorithm during continuous measurements will be optimised to increase the robustness of the algorithm against artefacts.
Measured: 3 Days
Standardise the measurement set-up and measurement protocol in routine AECOPD management.
Measured: 3 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Nick Hart, Principal investigator, Guy's and St Thomas' NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02721199
- Sponsor's protocol ID
- 178765
- Acronym
- EMGCOPD
- Status last verified
- Jan 2016
- First submitted
- 27 Jan 2016
- Last updated
- 19 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Factors Affecting Respiratory Muscle EMG Measurements During Hospital Admission With Acute Exacerbation of COPD
- ClinicalTrials.gov ID
- NCT02721199
- Acronym / sponsor ID
- EMGCOPD / 178765
- Conditions
- COPD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Mar 2016 (estimated)
- 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.
Acute exacerbations of COPD contribute to significant morbidity and mortality in the United Kingdom (UK). The ability to assess response to treatment during exacerbations that require hospitalisation would allow clinicians to better risk stratify patients for higher or lower level in-patient or out-patient care. Current methods of detecting clinical deterioration are validated in general medical populations and may lack sensitivity and specificity in patients with respiratory morbidity. The use of respiratory muscle EMG to assess neural respiratory drive (NRD) has been demonstrated to be a predictor of readmission in patients admitted to hospital with COPD. The technique has been applied on 'spot' readings of limited duration due to the need for hand analysis of the data. It has been performed by a trained clinical physiologist who removed any interference data and standardised the data gathered. New automated software allows for longer periods of observation, mostly unsupervised, and as a result, the NRD measurements are more likely to be affected by various sources of variability. The influence of clinical and physiological factors as they occur during routine clinical management, such as administration of bronchodilator medication, time of day of readings or proximity to chest physiotherapy, are not yet understood. This trial is designed to gather data to better understand these relationships with NRD.
Detailed description
Introduction Patients admitted to hospital with acute exacerbations of COPD are at risk of significant in-hospital morbidity and mortality. Current markers of treatment success involve the integration of basic physiological variables (respiratory rate, heart rate, oxygen saturations), clinical examination and patient reported symptoms changes. Whilst the use of these physiological parameters are gold standard there remains concern that patient deterioration is often not detected and escalated effectively. This has led to the development and implementation of a range of clinical physiological composite scores such as the medical early warning score or the National Health Service (NHS) early warning scores. However, these scores have been validated in general rather than specific populations and there are concerns regarding their use in respiratory patient groups.The use of the parasternal intercostal muscle EMG (EMGpara) has been reported to track clinical change and identify treatment failure during hospital admissions with acute exacerbations of COPD (AECOPD) in selected and unselected cohorts. In these pilot works measurements were taken on research equipment and data analysed individually by a trained physiologist. The clinical physiologist ensured standardisation of recording conditions such as proximity to medication, patient position, time of day and recent activity. The effect of such clinical and physiological factors on EMGpara was minimised by the operator with preventive measures, such as the control for the measurement time, the limitation of the recording duration and the exclusion of any artefactual changes in EMGpara. The development of automated software allows for frequent sampling and continuous monitoring, which will potentially permit earlier detection of clinical deterioration. With an automated system however, clinical and physiological factors need to be carefully considered, in particular when the measurement is performed in an unsupervised or less closely supervised environment. This feasibility study is therefore designed to investigate repeatability of EMGpara in hospital-based AECOPD management (i.e. EMGpara changes reflect changes in clinical status). It will give us insight into potential control/mitigation measures and their implementation, in order to ultimately minimise false readings.
Study objectives To investigate the clinical and physiological factors that may affect the measurement of EMGpara in acute setting so as to enhance the clinical effectiveness of EMGpara in identifying treatment failure and clinical deterioration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective Cohort | – | Other: Neural Respiratory Drive Automated EMGpara assessmentNeural Respiratory Drive Automated EMGpara assessment |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to St Thomas' Hospital with a primary diagnosis of an acute exacerbation of COPD.
Key inclusion criteria (4 listed)
- COPD (as defined by GOLD criteria
- Acute exacerbation of COPD necessitating hospital admission
- Expected to remain an inpatient for ≥ 24 hours
- Able to give informed consent to participation in the study
Key exclusion criteria (6 listed)
- Decompensated respiratory failure (pH < 7.35)
- Significant physical, social or psychiatric factors that would prevent compliance with trial protocol
- Aged < 35 years or aged > 85 years
- Pregnancy
- BMI > 30kg/m2
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 |
|---|---|---|
| Neural Respiratory Drive Automated EMGpara assessmentNeural respiratory drive will be measured using surface electrodes and nasal cannula . The 2nd intercostal space will be identified by bony landmarks and skin preparation will be performed using detergent wipes, followed by EMG preparation gel with final cleaning to remove exfoliated skin. Wet gel electrodes will be placed immediately adjacent to the sternal border in the 2nd intercostal space and will be connected to the automated EMG analysis system. Electrodes will remain in place for the duration of the study. A nasal cannula will be placed in the nose and detect pressure changes during respiration in order to ensure accurate detection of inspiratory cycle. In addition, an accelerometer will be attached to the thorax of the patient | Other | Prospective Cohort |
Primary outcome
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting Medication Intake
Time frame: 3 days
Noting all medications taken during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting oxygen therapy.
Time frame: 3 days
Noting oxygen therapy, if any during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting use of non invasive ventilation.
Time frame: 3 days
Noting use of non invasive ventilation, if any during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting intubation details.
Time frame: 3 days
Noting details if participant is intubated during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if participant is transferred to critical care.
Time frame: 3 days
Noting details if participant is transferred to critical care during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if participant takes part in a respiratory physiotherapy session.
Time frame: 3 days
Noting details if participant takes part in a respiratory physiotherapy session during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), physiological factors that change EMG parasternal readings. If participant goes into clinical respiratory deterioration by the need for treatment/care escalation.
Time frame: 3 days
Noting details if participant is intubated during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of COPD, the physiological factors that can change EMG parasternal readings. If participant goes into clinical respiratory deterioration National Early Warning Score (NEWS) CREWS
Time frame: 3 days
Noting details if participant is documented as being in clinical respiratory deterioration as defined by NEWS/CREWS during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if participant partakes in physical activity
Time frame: 3 days
Noting details if participant partakes in any physical activity during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), physiological factors that change EMG parasternal readings. Collecting information when participant sleeps
Time frame: 3 days
Noting details when participant sleeps during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if there is any postural change
Time frame: 3 days
Noting details if participant changes postural position during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day.
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting information if participant takes part in a rehabilitation physiotherapy session.
Time frame: 3 days
Noting details if participant takes part in a rehabilitation physiotherapy session during the time frame up to 3 days during the exacerbation of COPD. Information taken 4 times during the day at the same time each day
6 secondary outcomes
Is it possible to perform Continuous EMGpara acquisition in a clinical setting
Time frame: 3 Days
Continuous EMGpara acquisition in clinical setting, is it applicable.
Time frame: 3 Days
Continuous EMGpara acquisition in clinical setting, preliminary insights on device requirements for this environment.
Time frame: 3 Days
EMGpara trends as it relates to standardly used metrics, e.g. vital signs, patient-reported symptoms.
Time frame: 3 Days
Rhe automated neural respiratory drive (NRD) calculation algorithm during continuous measurements will be optimised to increase the robustness of the algorithm against artefacts.
Time frame: 3 Days
Standardise the measurement set-up and measurement protocol in routine AECOPD management.
Time frame: 3 Days
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 19 Dec 2016.
- 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.
Nick Hart principal investigator
Guy's and St Thomas' NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
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 4 inclusion and 6 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 19 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
During the course of an exacerbation of Chronic Obstructive Pulmonary Disease (COPD), the physiological factors that can change EMG parasternal readings. Collecting Medication Intake (time frame: 3 days). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Dec 2016.