Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Pilot Feasibility Study to Determine the Clinical Effectiveness of Neural Respiratory Drive (NRD) to Predict COPD Exacerbations at Home.
NCT number | NCT03443505 |
Other study ID # | 232384 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | February 13, 2018 |
Est. completion date | June 6, 2019 |
Verified date | October 2019 |
Source | Guy's and St Thomas' NHS Foundation Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 23 |
Est. completion date | June 6, 2019 |
Est. primary completion date | June 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility |
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 Integrated Respiratory Team 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Guys and St Thomas NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Guy's and St Thomas' NHS Foundation Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in NRD from baseline to day prior to an acute exacerbation of COPD. | 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. | 30 days | |
Secondary | Change in NRD from peak exacerbation (hospital) to recovery baseline (home) | Change in NRD (measured as EMGpara%max) from its peak during hospital admission to baseline which will occur during the recovery period at home. | 30 days | |
Secondary | Correlation of time to recovery as measured by NRD and EXACT-PRO | 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. | 30 days | |
Secondary | Correlation of NRD to EXACT-PRO from hospital discharge to recovery | NRD measurements will be compared to EXACT-PRO questionnaire scores to examine for a correlation between patient-reported symptoms and NRD. | 30 days | |
Secondary | Correlation of NRD to physical activity from hospital discharge to recovery | 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. | 30 days | |
Secondary | Physician-assessed exacerbation within 30-day post-discharge | 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. | 30 days | |
Secondary | Self-treated exacerbation within 30-day post-discharge | 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. | 30 days | |
Secondary | All cause hospital readmission within 30-day post-discharge | This data will be collected from electronic medical records. | 30 days | |
Secondary | Mortality within 30-day post-discharge | This data will be collected from electronic medical records and by contacting participants' primary care physicians if necessary. | 30 days | |
Secondary | Recovery as defined by the EXACT-PRO within 30-day post-discharge | Use of the EXACT-PRO score to identify time to recovery within the 30-day post-discharge period. | 30 days | |
Secondary | Medication change within 30-day post-discharge | Use of participants' symptom diary to identify COPD medication changes within 30-day post-discharge. | 30 days | |
Secondary | Unplanned healthcare contacts | Use of participants' symptom diaries and medical records to evaluate healthcare utilization in the 30-day post-discharge period. | 30 days | |
Secondary | Attendance of emergency department (without admission) | Use of participants' symptom diaries and medical records to evaluate healthcare utilization in the 30-day post-discharge period. | 30 days |
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