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NRD to Predict COPD Exacerbations at Home

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ClinicalTrials.gov Identifier: NCT03443505
Recruitment Status : Recruiting
First Posted : February 23, 2018
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Brief Summary:

COPD is a common, serious disease and is a major burden on patients and the National Health Service. Patients with COPD can develop worsening of their symptoms, known as an exacerbation, which can be severe enough to warrant hospital admission. There are currently no objective measurements available to patients and clinicians to predict exacerbation and monitor recovery. Detection of exacerbation by both patients and physicians is known to correlate poorly with onset of respiratory deterioration.

Measurement of neural respiratory drive (NRD), or drive to breathe, using respiratory muscle electromyography (EMG) correlates with changes in patients' symptoms and physician defined deterioration during hospital admissions.

This pilot study aims to identify whether daily measurement of NRD at home following admission to hospital with exacerbation of COPD can detect an exacerbation within 30 days of discharge (20% of patients are readmitted within this period). This technique could enable early detection of deterioration at home, facilitating earlier treatment compared to current practice, potentially avoiding hospital readmission.

30 patients admitted to St Thomas' Hospital because of an exacerbation of COPD aged 40-80, with a body mass index <35kg/m2, who can follow English instructions and give informed consent, who are discharged home will be recruited. If patients consent to participate, they will have assessments as inpatients and for 30 days at home following discharge, or until hospital readmission, whichever is sooner. Assessments include vital observations (heart rate, blood pressure, respiratory rate and oxygen saturations), NRD, and a symptom questionnaire. At the baseline assessment, age, height weight, a brief medical history, results of tests already taken by the clinical team (blood tests and chest x-ray) and lung function tests will be recorded. This study will take 12 months. Philips and its Affiliates are providing the NRD measuring equipment.


Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Diagnostic Test: Neural respiratory drive measurement

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Feasibility Study to Determine the Clinical Effectiveness of Neural Respiratory Drive (NRD) to Predict COPD Exacerbations at Home.
Actual Study Start Date : February 13, 2018
Estimated Primary Completion Date : July 13, 2019
Estimated Study Completion Date : July 13, 2019

Intervention Details:
  • Diagnostic Test: Neural respiratory drive measurement
    Neural respiratory drive (NRD) has been validated as an objective physiological biomarker in acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Change in NRD during hospital admission has been demonstrated to be a marker of physician-defined clinical deterioration. NRD is a non-invasive measurement that involves skin preparation with a gel and alcohol wipe before placing 3 surface electrodes on the chest wall and collar bone to perform electromyography (EMG) of parasternal muscles. Electrodes are connected to an automated EMG analysis system to derive a measurement of NRD. Measurements take approximately 10 minutes with subject being monitored during normal ("tidal") breathing and performing maximal sniff manoeuvres.


Primary Outcome Measures :
  1. Change in NRD from baseline to day prior to an acute exacerbation of COPD. [ Time Frame: 30 days ]
    Change in EMGpara%max (derived from RMS EMGpara and maximal sniff manoevres) from subjects' baseline NRD to the day before a clinical re-exacerbation of COPD following index hospitalisation with AECOPD.


Secondary Outcome Measures :
  1. Change in NRD from peak exacerbation (hospital) to recovery baseline (home) [ Time Frame: 30 days ]
    Change in NRD (measured as EMGpara%max) from its peak during hospital admission to baseline which will occur during the recovery period at home.

  2. Correlation of time to recovery as measured by NRD and EXACT-PRO [ Time Frame: 30 days ]
    Time to recover NRD from hospital peak to home baseline will be correlated with EXACT-PRO score. The EXACT-PRO score is designed to standardize the method for evaluating the frequency, severity and duration of both reported and unreported AECOPD in studies. The EXACT-PRO total score is computed across the 14 items and has a theoretical range of 0 to 100, with higher values indicating a more severe condition. Specifically, the changes in the total score may be used to define recovery from the primary exacerbation event.

  3. Correlation of NRD to EXACT-PRO from hospital discharge to recovery [ Time Frame: 30 days ]
    NRD measurements will be compared to EXACT-PRO questionnaire scores to examine for a correlation between patient-reported symptoms and NRD.

  4. Correlation of NRD to physical activity from hospital discharge to recovery [ Time Frame: 30 days ]
    NRD measurements will be compared to physical activity to examine for a correlation between physical activity and sleep-wake cycle and NRD. This correlation will be examined to evaluate physical activity as an additional advanced physiological biomarker to identify further re-exacerbations of COPD and predict readmission. It will be measured using physical activity monitors which are wrist-worn devices. Using an accelerometer, the physical activity monitor will collect data on total sleep time, time spent awake after sleep onset, sleep onset latency, sleep efficiency, average activity (counts/minute), maximum activity (counts/minute), mobile time, average mobile bout, immobile time and total wake and sleep times.

  5. Physician-assessed exacerbation within 30-day post-discharge [ Time Frame: 30 days ]
    Defined as "worsening respiratory symptoms (cough, wheeze, increased sputum production, increased volume of sputum and/or increased breathlessness) with physician assessment and COPD treatment escalated (increased beta-agonist use as inhaled or nebulized therapy and/or oral corticosteroids and/or oral antibiotics) by physician WITHOUT admission to hospital". This data will be obtained from medical records and participants' symptom diaries.

  6. Self-treated exacerbation within 30-day post-discharge [ Time Frame: 30 days ]
    Defined as "worsening respiratory symptoms (cough, wheeze, increased sputum production, increased volume of sputum and/or increased breathlessness) WITHOUT physician assessment but patient self-initiated AECOPD treatment (use of rescue pack of oral corticosteroids and/or oral antibiotics, depending on standard of care at clinical site)". This data will be obtained from participants' symptom diaries.

  7. All cause hospital readmission within 30-day post-discharge [ Time Frame: 30 days ]
    This data will be collected from electronic medical records.

  8. Mortality within 30-day post-discharge [ Time Frame: 30 days ]
    This data will be collected from electronic medical records and by contacting participants' primary care physicians if necessary.

  9. Recovery as defined by the EXACT-PRO within 30-day post-discharge [ Time Frame: 30 days ]
    Use of the EXACT-PRO score to identify time to recovery within the 30-day post-discharge period.

  10. Medication change within 30-day post-discharge [ Time Frame: 30 days ]
    Use of participants' symptom diary to identify COPD medication changes within 30-day post-discharge.

  11. Unplanned healthcare contacts [ Time Frame: 30 days ]
    Use of participants' symptom diaries and medical records to evaluate healthcare utilization in the 30-day post-discharge period.

  12. Attendance of emergency department (without admission) [ Time Frame: 30 days ]
    Use of participants' symptom diaries and medical records to evaluate healthcare utilization in the 30-day post-discharge period.



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to hospital with a primary diagnosis of an acute exacerbation of COPD.
Criteria

Inclusion Criteria:

  • Age 40-80 years
  • Patients hospitalized with a primary diagnosis of an acute exacerbation of COPD
  • Body mass index (BMI) ≤ 35 kg/m2
  • Cognitively and linguistically able to follow instructions given in English and provide informed consent
  • To be discharged to home following the hospitalization
  • Patient lives in the catchment area served by the Lane Fox Unit at Guy's and St Thomas' NHS Foundation Trust in a home environment deemed safe by the investigators to perform home assessments

Exclusion Criteria:

  • Previous home PAP (CPAP or NIV) therapy use within the past year, or post-discharge
  • Allergies to latex, metals or local anaesthetic agents
  • Wound or inflamed skin at parasternal location (2nd intercostal space)
  • History of skin allergies or sensitivity to cosmetics and lotions
  • Psychological and social factors that would impair compliance with study protocol and schedule
  • Any major non-COPD chronic disease or condition, such as severe heart failure (LVEF<30%), malignancy (active treatment and palliation), end stage renal failure/dialysis, significant neuromuscular disease (e.g. NMD, MD) determined by review of medical history and / or patient reported medical history that may contribute significantly to risk of readmission, as determined by PI
  • Length of stay ≤ 24 hours
  • Planned travel away from home within the 30 day post discharge period

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443505


Contacts
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Contact: Gill Arbane, BSc MRes 02071888070 ext 88070 gill.arbane@gstt.nhs.uk

Locations
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United Kingdom
Guys and St Thomas NHS Foundation Trust Recruiting
London, United Kingdom, SE1 7EH
Contact: Gill Arbane, BSc MRes    02071888070 ext 88070    gill.arbane@gstt.nhs.uk   
Contact: Nicholas Hart, MBBSPhDFFICM    02071888070 ext 88070    nicholas.hart@gstt.nhs.uk   
Principal Investigator: Patrick B Murphy, MBBSPhDMRCP         
Sub-Investigator: Rebecca F D'Cruz, MBBSBScMRCP         
Sub-Investigator: Eui-Sik Suh, MBBSMRCPPhD         
Sub-Investigator: Georgios Kaltsakas, MD PhD         
Sub-Investigator: Gill Arbane, BScMRes         
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
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Principal Investigator: Nicholas Hart, MBBSPhDFFICM Guy's and St Thomas' NHS Foundation Trust
  Study Documents (Full-Text)

Documents provided by Guy's and St Thomas' NHS Foundation Trust:
Study Protocol  [PDF] September 4, 2017
Informed Consent Form  [PDF] September 4, 2017


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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03443505     History of Changes
Other Study ID Numbers: 232384
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
Chronic obstructive pulmonary disease
Acute exacerbation
Neural respiratory drive
Parasternal electromyography
Respiratory physiology
Lung function

Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases