Myotrace: A Phase II Evaluation of a Novel Critical Illness Monitoring System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Readmission to hospital
研究概览
简要总结
There are 24,000 admissions each year to Intensive Care Units (ICU) in the United Kingdom due to pneumonia, asthma and a common condition called chronic obstructive pulmonary disease (COPD), with rates of death of 10%, 40% and 50%, respectively. These conditions account for 10% of all ICU admissions. It is therefore important to find out if it would be possible to detect deteriorations in patients with breathing problems early, in order to increase appropriately their level of care.
Clinical early warning scores (EWS) are used in many hospitals to detect patients whose medical condition is getting worse, and who are likely to need admission to intensive care or high dependency care units. EWS are usually calculated from several measurements taken from the patient, such as blood pressure, temperature and heart rate. However, they are often inaccurate as they need to be calculated manually by nursing staff from a number of measurements taken from a variety of different devices. Furthermore, even when accurately calculated, it is not clear how helpful EWS are in predicting whether or not patients will deteriorate.
Neural respiratory drive (NRD) is an objective indicator of breathlessness, and can be derived from the amount of electrical activity occurring in certain muscles used in breathing. The Myotrace system measures this electrical activity, as well as measurements such as rate of breathing and heart rate. It then analyses these measurements together to help identify patients at risk of deterioration.
This study will use Myotrace to monitor patients with severe breathing difficulties due to an acute worsening of chronic obstructive pulmonary disease, for early identification of failure to respond to medical treatment.
Patients will be recruited at St. Thomas' Hospital.
This research is funded by the Guy's and St. Thomas' Charity.
详细描述
Admissions to hospital due to breathing difficulties are common. When these patients' medical condition worsens, the deterioration is often not noticed until the patient needs to be moved to an area of the hospital that provides higher levels of care, e.g. intensive care unit or high-dependency unit.
Early warning scores (EWS) have been designed to help medical and nursing staff identify patients at risk of deteriorating. These scores are usually calculated from patient measurements such as blood pressure and heart rate. It is not clear how effective these scores are in preventing patient deterioration, or the need for intensive or high-dependency care. The investigators therefore need another means of identifying patients at risk of deterioration, particularly in those with breathing difficulties.
Neural respiratory drive is a term used to describe the nervous system's response to the need for increased breathing, and may be helpful in predicting whether patients admitted to hospital with breathing difficulties will deteriorate. This response may be measured as the amount of electrical activity that occurs in the muscles associated with breathing, which are supplied with nerves that deliver electrical messages to the fibres that make up muscle.
The main breathing muscle in the body is the diaphragm, a sheet of muscle lying beneath the lungs, which, when it contracts, moves downwards and draws air into the lungs. Although the electrical activity in the diaphragm may be measured, this can only be achieved using a technique that involves passing an electrical probe into a patient's oesophagus, or gullet. This is not easy to do in a patient that has been admitted unwell to hospital with breathing difficulties.
Therefore, a technique has been developed to measure the electrical activity that occurs in the parasternal muscles. These muscles lie either side of the sternum, or breast bone, and are particularly important breathing muscles in patients with chronic obstructive pulmonary disease (COPD), a lung disease commonly associated with smoking. Parasternal muscle electrical activity can be measured from probes attached to the skin of the chest wall, and can therefore be achieved more easily than measuring diaphragm electrical activity.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Admitted patients with physician diagnosis of AECOPD
- •Smoking history ≥ 10 pack years, consistent with COPD
- •Expected to remain an inpatient for ≥ 24 hours
- •Age ≥ 35 years
- •Able to give informed consent to participation in the study
排除标准
- •Requirement for immediate mechanical ventilation at admission
- •Presence of another acute pathology (such as pulmonary embolism, pneumonia or pulmonary oedema) to explain the acute presentation
- •Presence of other severe medical problem, e.g. cancer
- •Psychological and social factors that would impair compliance with the study schedule
结局指标
主要结局
Readmission to hospital
时间窗: 28 days
Readmission to hospital within 28 days of discharge, following acute exacerbation of COPD
次要结局
- Treatment failure(up to 1 month following admission)
- Length of hospital stay(expected to be 2-9 days)
- Physical activity(Up to 3 months after discharge from hospital)