EMG in COPD - Factor Analysis

NCT ID: NCT02721199

Last Updated: 2016-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-06-30

Brief 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. 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.

Conditions

COPD

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Prospective Cohort

Neural Respiratory Drive Automated EMGpara assessment

Neural Respiratory Drive Automated EMGpara assessment

Intervention Type: OTHER

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

Interventions

Neural Respiratory Drive Automated EMGpara assessment

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Healthcare

INDUSTRY

Sponsor Role: collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Hart

Role: PRINCIPAL_INVESTIGATOR

Guy's and St Thomas' NHS Foundation Trust

Locations

Guys and St Thomas NHS Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

178765

Identifier Type: -

Identifier Source: org_study_id