EMG in COPD - Factor Analysis

NCT02721199 | Completed

• 1 other identifier: 178765
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (12)

• 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.

  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.

  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.

  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.

  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.

  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

  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.

  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.

  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.

  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.

  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.

  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

  3 days

Secondary Outcomes (6)

• Is it possible to perform Continuous EMGpara acquisition in a clinical setting

  3 Days

• Continuous EMGpara acquisition in clinical setting, is it applicable.

  3 Days

• Continuous EMGpara acquisition in clinical setting, preliminary insights on device requirements for this environment.

  3 Days

• EMGpara trends as it relates to standardly used metrics, e.g. vital signs, patient-reported symptoms.

  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.

  3 Days

Study Arms (1)

Prospective Cohort

Neural Respiratory Drive Automated EMGpara assessment

Other: Neural Respiratory Drive Automated EMGpara assessment

Interventions

Neural Respiratory Drive Automated EMGpara assessment 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

Prospective Cohort

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to St Thomas' Hospital with a primary diagnosis of an acute exacerbation of COPD.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead
• Philips Healthcare: collaborator

Study Sites (1)

Guys and St Thomas NHS Trust

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nick Hart

  Guy's and St Thomas' NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2016
• First Posted: March 29, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 19, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)