跳至主要内容
临床试验/NCT02379065
NCT02379065已完成不适用

Mesh Nebuliser Versus Standard Jet Nebuliser Therapy in Acute Chronic Obstructive Pulmonary Disease in the Emergency Department

Chelsea and Westminster NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2015年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
2
主要终点
Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) - to be completed by both the patient and clinician

研究概览

简要总结

The investigators are looking at whether a new type of nebuliser (a machine used to deliver drugs to the airways) is better at delivering drugs to the lungs of people with Chronic Obstructive Pulmonary Disease (COPD), compared with the current nebulisers used in Emergency Departments. The investigators will randomly allocate patients who come into the Emergency Department with an acute episode of the COPD into either the standard nebuliser group or the new nebuliser group.

Both groups will receive the same medications, it is only the method of delivering them which will be different.

详细描述

Chronic Obstructive Pulmonary Disease presents a significant burden on Emergency Departments and acute medical services, accounting for approximately 90,000 hospital admissions a year, with an average stay lasting 11 days. COPD accounts for 10% of acute hospital admissions, therefore any method of improving health outcomes and reducing the burden on acute services will benefit patients twofold.

Severity of acute COPD is based on clinical indicators such as patient perceived breathlessness, arterial blood gas analysis and respiratory rate. Although breathlessness is a subjective marker, multiple scoring systems have been devised in an attempt to standardise this in order to see an objective improvement in the patient. One of the most commonly used and repeatedly validated scoring systems is the BORG score, which has been shown to effectively demonstrate improvement in breathlessness in the emergency setting .

Nebulised bronchodilator therapy is the mainstay of treatment, as described in the National Institute of Clinical Excellence guidelines. Delivery of bronchodilators (salbutamol and ipratropium) is through a standard facemask - in this Trust it is a Phillips Respironic© mask. Drugs delivery is variable through a nebuliser mask and it is difficult to measure exactly how much of the drug is being delivered to the more distal bronchial tree. Furthermore, this can be highly variable between patients depending on how well the mask fits and patient tolerance, amongst other factors.

Various attempts have been made to improve drug delivery in acute setting such as a spacer and a hood (within paediatric asthmatic patients) , . However, they have all showed that the clinical outcomes are the same regardless of the method of delivery.

Clinical assessment is based on a combination of objective and subjective parameters. Within the Emergency Department, these include both patient and clinician perception of improvement in symptoms (primarily shortness of breath). Assessment also includes more objective measurements such as oxygen saturation, arterial blood gas measurements and end tidal CO2 measurements when available.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Documented diagnosis of COPD
  • Smoking history of at least 10 pack years (i.e. 20 cigarettes a day for 10 years or equivalent) or other risk factor for COPD in history (e.g. occupational exposure or alpha 1 antitrypsin deficiency)
  • Age > 40 years old

排除标准

  • - A lack of valid consent from patient (e.g. reduced level of consciousness, dementia)
  • Patient unable to speak adequate English - as this study is being conducted in the Emergency Department, there is no access to translators
  • Patient refusal
  • Ambiguity over diagnosis of COPD e.g. possible underlying asthma
  • Patients where an alternate diagnosis (such as congestive cardiac failure) cannot be excluded as the acute medical problem leading to shortness of breath

结局指标

主要结局

Score on the Modified Borg Scale (an interval scale which runs from 0-10, with statements describing level of breathlessness as perceived by the patient) - to be completed by both the patient and clinician

时间窗: 4 hours

次要结局

未报告次要终点

研究者

发起方
Chelsea and Westminster NHS Foundation Trust
申办方类型
Other
责任方
Sponsor

研究点 (2)

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