Pilot Feasibility Study to Determine the Clinical Effectiveness of Neural Respiratory Drive (NRD) to Predict COPD Exacerbations at Home.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in NRD from baseline to day prior to an acute exacerbation of COPD.
研究概览
简要总结
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.
详细描述
Introduction
COPD is a common and serious disease, and is a major burden on patients and the National Health Service. Current markers to detect and monitor exacerbations and response to treatment are based on symptoms reported by patients, clinical assessment and Early Warning Scores, which are a composite measurement of standard observations, including heart rate, blood pressure, respiratory rate and oxygen saturations. However these scores have been validated on general populations and there is concern regarding their application to COPD patients. There is currently no objective biomarker to predict and monitor COPD exacerbations in routine clinical use.
NRD is measured using parasternal intercostal EMG measurements. Daily NRD measurements during hospital admission with exacerbation of COPD has been demonstrated to be a reproducible non-invasive measurement which is acceptable to patients. Importantly, it can reliably detect clinical deterioration and worsening in patient reported breathlessness more reliably than current standard assessments.
This observational pilot feasibility study is designed to identify whether NRD can be measured reliably at home following discharge from hospital with exacerbation of COPD, and whether it can detect respiratory deterioration within 30 days. This technique thus has the potential to allow early detection of deterioration at home, which can facilitate early treatment in the community and potentially avoid hospital readmission, which would have a profound impact on both patients and the NHS.
Study objectives
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in NRD from baseline to day prior to an acute exacerbation of COPD.
时间窗: 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.
次要结局
- Medication change within 30-day post-discharge(30 days)
- Change in NRD from peak exacerbation (hospital) to recovery baseline (home)(30 days)
- Correlation of time to recovery as measured by NRD and EXACT-PRO(30 days)
- Correlation of NRD to EXACT-PRO from hospital discharge to recovery(30 days)
- Correlation of NRD to physical activity from hospital discharge to recovery(30 days)
- Recovery as defined by the EXACT-PRO within 30-day post-discharge(30 days)
- Unplanned healthcare contacts(30 days)
- Mortality within 30-day post-discharge(30 days)
- Physician-assessed exacerbation within 30-day post-discharge(30 days)
- Self-treated exacerbation within 30-day post-discharge(30 days)
- All cause hospital readmission within 30-day post-discharge(30 days)
- Attendance of emergency department (without admission)(30 days)