Novel Sensors and Artificial Intelligence for Detection of Acute Pulmonary Exacerbations in Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The change in physiological parameter measure such as heart rate (sensor dependant) between the start and end of intravenous antibiotics for acute pulmonary exacerbation.
研究概览
简要总结
The goal of this observational study is to learn about new sensors that measure changes in the body that happen during a chest infection, such as breathing rate and heart rate. This study will be with adults who have either cystic fibrosis or bronchiectasis who start treatment with intravenous antibiotics (usually for around 2 weeks).
The main question it aims to answer is the change in sensor measure (such as heart rate) between the start and end of treatment for a chest infection.
No follow up visits are required for this study.
详细描述
Primary Research Question Can novel sensors and artificial intelligence (AI) be used to detect acute pulmonary exacerbations (APEs) before becoming clinically apparent in patients with cystic fibrosis (CF) or non-cystic fibrosis bronchiectasis (non-CF bronchiectasis)?
Background Bronchiectasis is a clinical syndrome defined by abnormal, usually permanent dilatation of the bronchi associated with cough and sputum production. In addition, for many patients the daily symptoms of the disease are accompanied by unpredictable worsening of symptoms greater than the normal day-to-day variation and referred to as Acute Pulmonary Exacerbations (APEs).
CF is a life limiting, inherited condition that causes a build-up of thick, sticky secretions in the lungs (and other organs) that leads to severe and persistent bacterial infections. CF is characterised by periods of relative stability punctuated by abrupt clinical deterioration, known as APEs, which drive pulmonary inflammation, progressive lung damage and premature death.
Symptoms of APEs include change in sputum volume or colour, increased cough, increased dyspnoea, malaise, fatigue, or lethargy, temperature above 38°C, anorexia or weight loss. Change in physical examination of the chest, decrease in pulmonary function and / or radiographic changes indicative of pulmonary infection may also be seen.
APEs have a significant impact on patient outcomes. Severe APEs have been linked to accelerated lung function decline and patients with frequent APEs, particularly those experiencing three or more APEs per year, have a worse quality of life, more frequent hospitalisations, and increased mortality over 5 years. APEs are also a major contributor to healthcare cost.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Diagnosis of CF based on genetic testing and /or sweat chloride levels or CT confirmed diagnosis of non-CF bronchiectasis
- •Under the care of Royal Papworth Hospital
- •Starting IV antibiotics for treatment of APE as defined by the Hill Criteria ²
排除标准
- •Patients unable to provide written informed consent
- •Lung transplant recipients or on lung transplant waiting list
- •Use of long-term oxygen therapy (LTOT) or non-invasive ventilation to manage respiratory failure
- •Patients unwilling to consent to their link anonymised data from home monitoring being used for research
- •Considered unsuitable for home monitoring in the opinion of the investigator
- •Patients being admitted for elective antibiotic treatment (i.e. not being admitted for acute APE treatment)
结局指标
主要结局
The change in physiological parameter measure such as heart rate (sensor dependant) between the start and end of intravenous antibiotics for acute pulmonary exacerbation.
时间窗: from enrolment to the end of treatment at 14 days (may be 10-21 days depending on length of treatment course)
mean of parameter (e.g. heart rate) taken from first 2 days of IV antibiotics vs the last 2 days of antibiotics will be compared
次要结局
未报告次要终点